Law on the circulation of biomedical cell products. How the Law “On Biomedical Cell Products” will affect Russian innovation Law on the Procurement of Biomedical Cell Materials

Registration No. 47615

Approved
Ministry of Health
Russian Federation
dated March 31, 2017 No. 143n

The procedure for posting information related to the implementation of state registration of biomedical cellular products, including conducting biomedical examination of biomedical cell products and their ethical examination, information on registered biomedical cell products and biomedical cell products excluded from the state register of biomedical cell products

1. This Procedure determines the rules for posting on the official website of the Ministry of Health of the Russian Federation (hereinafter referred to as the Ministry) on the Internet information and telecommunications network (hereinafter referred to as the official website) information related to the state registration of biomedical cell products, including the conduct of biomedical examination of biomedical cell products and ethical examination of the possibility of conducting a clinical trial of a biomedical cell product (hereinafter - ethical examination), information on registered biomedical cell products and biomedical cell products excluded from the state register of biomedical cell products (hereinafter - information).

2. Information is posted on the official website by the Department of State Regulation of the Circulation of Medicines of the Ministry and is provided by the system information resources of the Ministry through the organization of an electronic database (hereinafter referred to as the database).

3. Information posted on the official website includes the following information about the stages of procedures carried out in relation to a specific biomedical cell product:

1) details of the applications specified in this Procedure;

2) name of the biomedical cell product and type of biomedical cell product (allogeneic, autologous or combined);

3) name and address of the applicant;

4) name and address of the manufacturer of biomedical cell products;

5) names (international non-proprietary, or group, or chemical) of medicinal products for medical use, included in the biomedical cell product, dates and numbers of registration certificates of medicinal products;

6) names of medical devices included in the biomedical cellular product, dates and numbers of registration certificates for medical products;

7) details of the Ministry’s decisions on issuing assignments to conduct a biomedical examination of a biomedical cell product, details of the Ministry’s requests to clarify the information contained in the documents submitted by the applicant;

8) details of the ethics council’s conclusion on the possibility or impossibility of conducting clinical trials biomedical cell products;

9) details of the Ministry’s decision to renew state registration of a biomedical cell product or to refuse to renew state registration of a biomedical cell product, details of the Ministry’s decision to terminate state registration of a biomedical cell product;

10) details of the Ministry’s decisions on re-conducting biomedical examination of a biomedical cell product and (or) ethical examination;

11) details of the conclusions of the commission of experts of the federal state budgetary institution, which is under the jurisdiction of the Ministry and ensures the execution of the powers of the Ministry to issue permits for clinical trials of biomedical cell products and (or) state registration of biomedical cell products, based on the results of biomedical examination of the biomedical cell product;

12) details of the decision of the Ministry to issue a permit to conduct clinical trials of biomedical cell products, including an international multicenter clinical trial of a biomedical cell product or a post-registration clinical trial of a biomedical cell product, or to refuse to issue the said permit;

13) details of the decision of the Ministry on state registration of a biomedical cellular product or on refusal of state registration of a biomedical cellular product;

14) details of the decision of the Ministry to confirm the state registration of a biomedical cell product or to refuse to confirm the state registration of a biomedical cell product;

15) details of the decision of the Ministry to make changes to the documents contained in the registration dossier for a registered biomedical cell product, or to refuse to make changes to the documents contained in the registration dossier for a registered biomedical cell product.

4. The information specified in this Procedure is placed in the database no later than five working days from the date the Ministry receives the applications specified in this Procedure.

The information specified in this Procedure is placed in the database within three working days from the date the Ministry makes the relevant decision, the Ministry receives the corresponding conclusion, an application for renewal of state registration of a biomedical cell product, or the Ministry sends a corresponding request to the applicant.

5. Access to the database is provided to the following subjects of circulation of biomedical cell products (hereinafter referred to as the applicant):

1) an organization that has rights to the results of preclinical studies of a biomedical cell product, clinical studies of a biomedical cell product and (or) the production technology of a biomedical cell product, which has submitted to the Ministry an application for state registration of a biomedical cell product;

2) the owner of the registration certificate of the biomedical cell product, who has submitted to the Ministry an application for confirmation of state registration of the biomedical cell product;

3) the owner of the registration certificate of the biomedical cell product, who has submitted to the Ministry an application to amend the documents contained in the registration dossier for the registered biomedical cell product;

4) an organization that organizes a clinical trial of a biomedical cell product and has submitted to the Ministry an application for permission to conduct an international multicenter clinical trial of a biomedical cell product or a post-registration clinical trial of a biomedical cell product.

6. The applicant’s access to the database is carried out by providing the applicant with a personal login by the Department of Information Technologies and Communications of the Ministry within 5 working days from the date the Ministry receives an application for access to the database.

7. The basis for refusal to provide access to the database is the lack of a person’s status as an applicant specified in this Procedure in relation to a specific biomedical cell product.

If a reason is established for refusal to provide access to the database, the Department of Information Technologies and Communications of the Ministry sends (hands over) to the applicant a reasoned refusal in writing or in the form of an electronic document.

8. The Department of Information Technologies and Communications of the Ministry at least once a day creates a backup copy of the database in order to protect the information contained in it, and also protects the information contained in the database from unauthorized access.

Document overview

The issues of posting information related to the state registration of biomedical cell products (BCPs), including the conduct of biomedical and ethical examination, data on registered BCPs and those excluded from the register have been resolved.

Information is published on the website of the Russian Ministry of Health. A special database is being formed. The order of access to it is fixed.

The composition of the posted information has been determined. The deadlines for their submission are indicated.

A.N. Borisov., A.M. Borisova

Commentary to the Federal Law of June 23, 2016 No. 180-FZ “On Biomedical Cell Products” (article-by-article)

COMMENTARY TO FEDERAL LAW

"ON BIOMEDICAL CELL PRODUCTS"

(ITEMIZED)

Borisov A.N., Borisova M.A.

Commentary to Federal Law of June 23, 2016 No. 180-FZ “On Biomedical Cell Products” (Itemized) / A.N. Borisov, M.A. Borisova. – M.: Yustitsinform, 2017. – 420 p.

978-5-7205-1411-2

In this book the issues of development, preclinical and clinical research, expertise, state registration, production, quality control, implementation, application, storage and transportation of biomedical cell products (BCP) are considered in detail.

The norms of considered law are analyzed in conjunction with the norms of the Federal Laws “On Fundamentals of Health Care of Citizens in the Russian Federation” and “On Circulation of Medicines”. Comparison with the provisions of the EU Directive “On Establishing Quality and Safety Standards for Donation, Acquisition, Control, Processing, Conservation, Storage and Distribution of Human Tissues and Cells” is held.

The book is intended, first of all, for law enforcers – persons of the sphere of circulation of the BCR The book will also be useful to everyone who is interested in the issues of legal regulation of this sphere in Russia.

Keywords: biomedical cell products, donation, registration of biomedical cell products, state regulation and control in the field of biomedical cell products, biomedical expertise.

List of abbreviations

Government bodies, other government bodies and organizations:

EAEU – Eurasian Economic Union;

State Duma – State Duma of the Federal Assembly of the Russian Federation;

Russian Armed Forces – Supreme Court of the Russian Federation;

SAC of Russia – Supreme Arbitration Court of the Russian Federation;

Treasury of Russia - Federal Treasury;

Ministry of Health of Russia - Ministry of Health of the Russian Federation;

Ministry of Health and Social Development of Russia – Ministry of Health and social development Russian Federation;

Ministry of Justice of Russia - Ministry of Justice of the Russian Federation;

Roszdravnadzor – Federal Service for Surveillance in Healthcare;

Federal Tax Service of Russia - Federal Tax Service;

FCS of Russia - Federal Customs Service;

Rosimushchestvo – Federal Agency for State Property Management;

FSBI "NTsESMP" of the Ministry of Health of the Russian Federation is a federal state budgetary institution "Scientific Center for Expertise of Medicinal Products" of the Ministry of Health of the Russian Federation.

Legal acts:

EU Human Tissue and Cell Directive (2004) – Directive No. 2004/23/EC of the European Parliament and of the Council on the establishment of quality and safety standards for the donation, acquisition, control, processing, preservation, storage and distribution of human tissues and cells”, adopted in Strasbourg on March 31, 2004;

part four of the Civil Code of the Civil Code of the Civil Code (Part 4)

Law of 2010 on Medicines – Federal Law of April 12, 2010 No. 61-FZ “On the Circulation of Medicines”;

Law of 2011 on health protection - Federal Law of November 21, 2011 No. 323-FZ “On the fundamentals of protecting the health of citizens in the Russian Federation”;

draft Law in connection with the adoption of the commented Law (2016) - draft Federal Law“On amendments to certain legislative acts of the Russian Federation in connection with the adoption of the Federal Law “On Biomedical Cell Products”, prepared by the Ministry of Health of the Russian Federation, but not submitted to the State Duma of the Federal Assembly of the Russian Federation (October 5, 2016).

Sources of legal acts:

pravo.gov.ru – “Official Internet portal of legal information http://www.pravo.gov.ru”;

regulation.gov.ru – “Official website for posting information on the preparation by federal executive authorities of draft regulatory legal acts and the results of their public discussion http://regulation.gov.ru (federal portal of draft regulatory legal acts)”;

BNA Federal Executive Authority - “Bulletin of normative acts of federal executive authorities”;

Gazette of the USSR Armed Forces - “Gazette of the Supreme Soviet of the USSR”;

Gazette SPD and VS RF "Gazette of the Congress of People's

deputies of the Russian Federation and the Supreme Council of the Russian Federation";

RG – “Rossiyskaya Gazeta”;

SZ RF – “Collection of Legislation of the Russian Federation”;

SPS – reference legal systems.

Other abbreviations:

BMCP – biomedical cell product (biomedical cell products);

Unified State Register of Individual Entrepreneurs;

Unified State Register of Legal Entities - unified state register legal entities.

Introduction

The publication of a separate legal act, which will regulate the development, production and medical use of BMCP, in the form of the Federal Law “On the Circulation of Biomedical Cell Products” was planned for 2014 by the State Program of the Russian Federation “Health Development”, approved. by Decree of the Government of the Russian Federation of December 24, 2012 No. 2511-r (recognized as invalid by Decree of the Government of the Russian Federation of April 15, 2014 No. 294 “On approval state program Russian Federation “Health Development”). Accordingly, in January 2013, the Russian Ministry of Health submitted for discussion the draft Federal Law “On the Circulation of Biomedical Cell Products.” However, the development of the corresponding bill was carried out earlier. Thus, back in December 2010, the Russian Ministry of Health and Social Development presented a draft Federal Law “On Biomedical Cell Technologies.”

Prior to this, relevant issues were regulated in fragments. Thus, the relevant act was only Order of the Ministry of Health of Russia dated July 25, 2003 No. 325 “On the development of cellular technologies in the Russian Federation”, which approved the Instructions for the procurement of umbilical cord/placental blood for research work, Instructions for the isolation and storage of stem cell concentrate human cord/placental blood and Regulations on the Human Cord/Placental Blood Stem Cell Bank. The bill was submitted to the State Duma by the Government of the Russian Federation two years later in February 2015 (see Decree of the Government of the Russian Federation dated February 5, 2015 No. 160-r) - with amendments, including with the clarified name “On biomedical cell products " As noted, the bill was prepared taking into account the analysis of international experience, foreign law enforcement practice and is aimed at regulating relations arising in connection with the development, preclinical studies, examination, state registration, clinical trials, production, sale, storage, transportation, use, destruction , import into Russia, export from Russia of biomedical cell products for the prevention, diagnosis and treatment of diseases (conditions) of the patient, maintenance of pregnancy and medical rehabilitation of the patient, as well as donation biological material for the production of BMCP. It was also noted that the adoption of the bill and the implementation of a set of measures are aimed at developing the biomedical technology sector in Russia.

Regarding the concept of the bill, the explanatory note to it states the following:

For the first time, the concepts of “biomedical cell product”, “cell line”, “cell differentiation”, “donor of biological material”, “safety of a biomedical cell product”, “efficiency of a biomedical cell product” and other concepts that are fundamentally important for the implementation of treatment are defined at the legislative level BMCP;

The bill defines the rights and obligations of the subjects of circulation of BMCP - individuals, including individual entrepreneurs, and legal entities carrying out activities when circulating BMCP;

The bill provides for state control (supervision) in the sphere of circulation of BMCP, which includes licensing control in the sphere of production of BMCP and federal state supervision in the sphere of circulation of BMCP;

BMCP will be used for the diagnosis, treatment and prevention of diseases with direct introduction into the human body, which, if used incorrectly, can lead to significant damage to human health. In order to ensure the safety and effectiveness of the use of BMCP, the bill provides for a biomedical examination of BMCP;

About biomedical cell products

Article 1. Subject of regulation of this Federal Law

1. This Federal Law regulates relations arising in connection with the development, preclinical studies, clinical trials, examination, state registration, production, quality control, sales, use, storage, transportation, import into the Russian Federation, export from the Russian Federation, destruction of biomedical cell products intended for the prevention, diagnosis and treatment of diseases or conditions of the patient, maintenance of pregnancy and medical rehabilitation of the patient (hereinafter referred to as the circulation of biomedical cell products), and also regulates relations arising in connection with the donation of biological material for the purpose of production of biomedical cell products.

2. This Federal Law does not apply to relations arising in the development and production of medicines and medical devices, donation of human organs and tissues for the purpose of transplantation (transplantation), donation of blood and its components, when using human germ cells for the purpose of using auxiliary reproductive technologies, as well as on the relationships that arise during the circulation of human cells and tissues for scientific and educational purposes.

Article 2. Basic concepts used in this Federal Law

This Federal Law uses the following basic concepts:

1) biomedical cell product - a complex consisting of a cell line (cell lines) and excipients or a cell line (cell lines) and excipients in combination with state-registered medicinal products for medical use (hereinafter referred to as medicinal products), and ( or) pharmaceutical substances included in the state register of medicines, and (or) medical products;

2) sale of a biomedical cellular product - transfer of a biomedical cellular product on a reimbursable basis and (or) free of charge;

3) autologous biomedical cell product - a biomedical cell product containing a cell line (cell lines) obtained from biological material a certain person, and intended for use by the same person;

4) allogeneic biomedical cell product - a biomedical cell product containing a cell line (cell lines) obtained from the biological material of a certain person and intended for use by other people;

5) combined biomedical cell product - a biomedical cell product containing cell lines obtained from the biological material of several people and intended for use by one of them;

6) sample of a biomedical cell product - a biomedical cell product or part thereof, obtained for the purpose of studying its properties, including to assess the quality of the biomedical cell product and its safety;

7) cell line - a standardized population of cells of the same type with a reproducible cellular composition, obtained by removing biological material from the human body with subsequent cultivation of cells outside the human body;

8) excipients - substances of inorganic or organic origin used in the development and production of a biomedical cell product;

9) biological material - biological fluids, tissues, cells, secretions and human waste products, physiological and pathological discharge, smears, scrapings, washings, biopsy material;

10) donor of biological material (hereinafter also referred to as donor) - a person who provided biological material during his lifetime, or a person from whom biological material was obtained after his death, ascertained in accordance with the procedure, established by law Russian Federation;

11) donation of biological material - the process of posthumous provision of biological material (hereinafter - posthumous donation) or lifetime provision of biological material (hereinafter - lifetime donation);

Article 1. Subject of regulation of this Federal Law

Article 2. Basic concepts used in this Federal Law

This Federal Law uses the following basic concepts:

2) sale of a biomedical cellular product - transfer of a biomedical cellular product on a reimbursable basis and (or) free of charge;

3) autologous biomedical cell product - a biomedical cell product containing a cell line (cell lines) obtained from the biological material of a certain person and intended for use by that same person;

4) allogeneic biomedical cell product - a biomedical cell product containing a cell line (cell lines) obtained from the biological material of a certain person and intended for use by other people;

5) combined biomedical cell product - a biomedical cell product containing cell lines obtained from the biological material of several people and intended for use by one of them;

8) excipients - substances of inorganic or organic origin used in the development and production of a biomedical cell product;

9) biological material - biological fluids, tissues, cells, secretions and human waste products, physiological and pathological secretions, smears, scrapings, washings, biopsy material;

10) donor of biological material (hereinafter also referred to as donor) - a person who provided biological material during his lifetime, or a person from whom biological material was obtained after his death, ascertained in the manner established by the legislation of the Russian Federation;

12) regulatory documentation for a biomedical cell product - a document developed by the manufacturer of a biomedical cell product containing a list of quality indicators of a biomedical cell product, determined based on the results of relevant examinations, and information on methods for quality control of a biomedical cell product;

13) quality of a biomedical cell product - compliance of a biomedical cell product with the requirements of regulatory documentation for a biomedical cell product;

14) safety of a biomedical cell product - characteristics of a biomedical cell product based on comparative analysis its effectiveness and the risk of harm to human life and health when used;

15) effectiveness of a biomedical cell product - degree characteristic positive influence biomedical cellular product for the course, duration of a disease or condition or for their prevention, for maintaining pregnancy, for medical rehabilitation of the patient;

16) protocol for a clinical trial of a biomedical cellular product - a document defining the goals of a clinical trial of a biomedical cellular product, the forms of its organization and methodology, statistical methods for processing research results and measures to ensure the safety of patients participating in a clinical trial of a biomedical cellular product;

17) patient information sheet - a document that sets out in an accessible form information about a clinical trial of a biomedical cellular product, its goals, plan of conduct and possible risks, the composition of the biomedical cellular product and contains the patient’s written voluntary consent to participate in a clinical trial of a biomedical cellular product;

18) registration certificate of a biomedical cellular product - a document confirming the fact of state registration of a biomedical cellular product;

19) manufacturer of a biomedical cellular product - an organization engaged in the production of a biomedical cellular product at one stage, several or all stages of the technological process in accordance with a license to carry out activities for the production of biomedical cellular products;

20) side effect - a reaction of the human body associated with the use of a biomedical cell product in accordance with the instructions for its use;

21) adverse reaction - an unfavorable reaction of the human body that may be associated with the use of a biomedical cell product;

22) serious adverse reaction - an adverse reaction of the human body, which is associated with the use of a biomedical cell product in accordance with the instructions for its use, leading to death, congenital anomalies or malformations, or posing a threat to human life, requiring hospitalization or leading to temporary disability or to disability;

23) unexpected adverse reaction - an adverse reaction of the human body that is associated with the use of a biomedical cell product in accordance with the clinical trial protocol of the biomedical cell product, the investigator’s brochure or instructions for its use and the essence, severity and outcome of which do not correspond to the information about the biomedical cell product, contained in the specified documents;

24) falsified biomedical cell product - a biomedical cell product deliberately accompanied by false information about its composition and (or) manufacturer;

25) substandard biomedical cell product - a biomedical cell product that does not meet the requirements of regulatory documentation for a biomedical cell product;

26) counterfeit biomedical cell product - a biomedical cell product that is in circulation in violation of civil law;

27) preclinical study of a biomedical cell product - biological, microbiological, immunological, toxicological, pharmacological, physical, chemical and other studies of a biomedical cell product in order to identify the specific mechanism of action of such a product, obtain evidence of its safety, quality and effectiveness, preceding a clinical study of a biomedical cell product product;

28) clinical study of a biomedical cellular product - the study of the preventive, diagnostic, therapeutic, rehabilitation properties of a biomedical cellular product during its use to humans in order to obtain evidence of its safety and effectiveness, data on side effects such a product and adverse reactions related to its use, as well as the effect of interaction of the biomedical cell product under study with other biomedical cell products, drugs and (or) medical devices, food products;

29) multicenter clinical trial of a biomedical cell product - a clinical trial of a biomedical cell product conducted in two or more medical organizations according to a unified protocol for clinical research of a biomedical cell product;

30) international multicenter clinical trial of a biomedical cellular product - a clinical trial of a biomedical cellular product conducted in various countries according to a unified protocol for the clinical trial of a biomedical cellular product;

31) post-registration clinical trial of a biomedical cell product - a clinical trial of a biomedical cell product, the circulation of which in the Russian Federation is carried out after state registration, for the purpose of additional collection of data on its safety and effectiveness, expanding the indications for the use of such a biomedical cell product, as well as identifying adverse reactions for its use.

Article 3. Principles for carrying out activities in the field of circulation of biomedical cell products

The principles for carrying out activities in the field of circulation of biomedical cell products are:

1) voluntary and free donation of biological material;

2) compliance with medical confidentiality and other secrets protected by law;

3) inadmissibility of purchase and sale of biological material;

4) the inadmissibility of creating a human embryo for the purpose of producing biomedical cell products;

5) the inadmissibility of using for the development, production and use of biomedical cell products biological material obtained by interrupting the development process of a human embryo or fetus or disrupting such a process;

6) compliance with biological safety requirements in order to protect the health of donors of biological material, workers involved in the production of biomedical cell products, medical workers, patients and environment.

Article 4. Cell line preparation

1. Preparation of a cell line intended for the production of biomedical cell products includes obtaining biological material, its study, isolation of cells from it, their cultivation and modification outside the human body, obtaining a standardized cell population and assessing the compliance of the cell population with the specifications for the biomedical cell product , containing information established by Article 7 of this Federal Law.

2. To prepare a cell line, only human cells or human cells in respect of whom death has been declared are used in the manner established by the legislation of the Russian Federation.

3. Receipt and use for the production of biomedical cell products of biological material from unidentified persons who, for health reasons, age or other reasons, could not provide information about their identity, in respect of whom death was subsequently declared in the manner established by the legislation of the Russian Federation and at the time of receipt biological material whose identity has not been established is not allowed.

Article 5. Development of biomedical cell products

1. Biomedical cell product development is the process of creating a biomedical cell product and its production technology.

2. Financial support for the development of biomedical cell products can be provided through:

3. The rights of the developer of a biomedical cell product are protected in accordance with civil law.

Article 6. Preclinical study of a biomedical cell product

1. Preclinical research of a biomedical cellular product is carried out on animals modeled in the body or outside a living organism pathological processes, occurring in the human body, and (or) human pathological conditions in which the biomedical cell product being developed is supposed to be used, as well as on models that make it possible to identify the specific mechanism of action of such a product, its effectiveness and safety.

2. Based on the results of the preclinical study of the biomedical cell product, the organization that conducted the preclinical study draws up a report on the preclinical study of the biomedical cell product, containing a description, results and analysis of the results of the preclinical study, as well as a conclusion on the possibility of conducting a clinical study of the biomedical cell product.

3. Rules for conducting preclinical studies of biomedical cell products, including requirements for the qualifications of specialists and the material and technical base of scientific organizations and educational organizations higher education, educational organizations of additional vocational education, other organizations, are established by the rules good practice for working with biomedical cell products approved by the federal executive body that carries out the functions of developing and implementing state policy and legal regulation in the field of healthcare (hereinafter referred to as the authorized federal executive body).

4. Financial support for preclinical research of biomedical cell products can be provided through:

1) budgetary allocations of the federal budget;

2) budgetary allocations to the budgets of the constituent entities of the Russian Federation;

3) funds for developers of biomedical cell products;

4) other sources not prohibited by the legislation of the Russian Federation.

Article 7. Biomedical Cell Product Specification

1. For each developed biomedical cell product that has undergone preclinical research, the developer of the biomedical cell product or the manufacturer of the biomedical cell product draws up a specification, which is a document containing information about the type (autologous, allogeneic, combined) of the biomedical cell product, its qualitative composition and quantitative composition , biological and other characteristics of the cell line(s) and biomedical cell product.

2. The specification form for a biomedical cell product is approved by the authorized federal executive body.

Article 8. State registration of biomedical cell products

1. Production, sale, use, storage, transportation, import into the Russian Federation, export from the Russian Federation, destruction of biomedical cell products are carried out if they are registered by the authorized federal executive body.

2. The following are subject to state registration:

1) all biomedical cell products to be put into circulation for the first time in the Russian Federation;

2) biomedical cell products registered previously, in the event of a change in the type (autologous, allogeneic, combined) of the biomedical cell product, its qualitative composition and (or) quantitative composition (except for the composition of excipients), biological and other characteristics of the cell line (cell lines) ) and biomedical cell product.

3. State registration of a biomedical cell product is carried out based on the results of:

1) biomedical examination of a biomedical cell product, including:

a) examination of the quality of a biomedical cell product, including examination of the composition of samples of a biomedical cell product and methods for controlling its quality (hereinafter referred to as examination of the quality of a biomedical cell product);

b) examination of documents to obtain permission to conduct a clinical trial of a biomedical cell product;

c) examination of the effectiveness of a biomedical cell product;

d) examination of the relationship between expected benefit and possible risk application of a biomedical cell product;

2) ethical review of the possibility of conducting a clinical trial of a biomedical cell product (hereinafter referred to as the ethical review);

3) clinical trials of a biomedical cell product.

4. State registration of biomedical cell products is carried out by the authorized federal executive body within a period not exceeding one hundred and fifty working days from the date of acceptance of the application for state registration of a biomedical cell product, or within a period not exceeding two hundred and fifty working days from the date of acceptance of the application for state registration biomedical cellular product, if the authorized federal executive body makes a decision to re-conduct the biomedical examination of the biomedical cellular product and (or) ethical examination in accordance with Article 19 of this Federal Law. The period for state registration of a biomedical cell product is calculated from the date the authorized federal executive body accepts an application for state registration of a biomedical cell product with an appendix necessary documents before the day of issue of the registration certificate of the biomedical cell product. The time of conducting a clinical trial of a biomedical cell product is not taken into account when calculating the period of state registration of a biomedical cell product.

5. State registration is not allowed:

1) various biomedical cell products under the same trade name;

2) one biomedical cell product produced by the manufacturer under various trade names and submitted for state registration in the form of two or more biomedical cell products.

6. The authorized federal executive body, in the manner established by it, at the request of legal entities operating in the circulation of biomedical cellular products (hereinafter referred to as the subjects of circulation of biomedical cellular products), provides in written or electronic form explanations of the provisions of the documentation related to state registration, as well as with preclinical and clinical studies of biomedical cell products.

Article 9. Submission of documents for state registration of biomedical cell product

1. For state registration of a biomedical cell product, an organization that has rights to the results of preclinical studies of a biomedical cell product, clinical studies of a biomedical cell product and (or) the production technology of a biomedical cell product, or another legal entity authorized by it (hereinafter referred to as the applicant), submits to the authorized federal executive body application for state registration of a biomedical cell product and other documents from which the registration dossier for a biomedical cell product is formed. The form of the application and the procedure for submitting the said application and documents, including the stages of submission (for biomedical cell products for which clinical trials have not been conducted on the territory of the Russian Federation), are established by the authorized federal executive body.

2. The registration dossier for a biomedical cell product is formed from the following documents:

1) application for state registration of a biomedical cell product;

2) a copy of a document in Russian, certified in the prescribed manner and confirming the applicant’s competence to submit an application for state registration of a biomedical cell product (power of attorney);

3) specification for a biomedical cell product;

4) draft regulatory documentation for a biomedical cell product;

5) draft layouts of primary packaging and secondary packaging of a biomedical cellular product;

6) a report on a preclinical study of a biomedical cell product;

7) draft protocol for a clinical trial of a biomedical cell product;

8) draft regulations for the production of biomedical cell products;

9) a copy of the license to carry out activities for the production of a biomedical cell product;

10) patient information sheet;

11) information on insurance payments to patients involved in conducting a clinical trial of a biomedical cell product;

12) a report on the results of international multicenter clinical studies of a biomedical cell product, some of which were conducted in the Russian Federation;

13) draft instructions for use of a biomedical cell product, containing the following information:

a) name of the biomedical cell product;

b) type of biomedical cell product (autologous, allogeneic, combined);

c) qualitative and quantitative characteristics of the cell line (cell lines), names and quantities of excipients included in the composition of the biomedical cell product;

d) names (international non-proprietary, or group, or chemical) and quantity of drugs included in the composition of the biomedical cell product;

e) names of medical devices included in the biomedical cellular product;

f) indications for use;

g) contraindications for use;

h) regimen and method of use of the biomedical cell product, duration of treatment;

i) precautions when using a biomedical cell product;

j) indication (if any) of the characteristics of the action of the biomedical cell product upon its first use;

k) possible side effects when using a biomedical cell product;

l) compatibility with other types of treatment, including compatibility with drugs and (or) medical devices, other biomedical cell products, as well as food products;

m) expiration date and indication of the prohibition of use of the biomedical cell product after the expiration date;

o) features of use in children, pregnant women and women during breastfeeding;

o) data on the stability of the biomedical cell product;

p) storage conditions of the biomedical cell product;

14) details of documents confirming payment of the state fee for conducting an examination of the effectiveness of a biomedical cell product and an examination of the ratio of the expected benefit to the possible risk of using a biomedical cell product, in respect of which international multicenter clinical trials have been conducted, some of which were conducted in the Russian Federation;

15) documents submitted in accordance with Part 2 of Article 18 of this Federal Law.

3. The applicant has the right to submit own initiative documents confirming payment of the state fee for conducting an examination of the quality of a biomedical cell product, examination of documents for obtaining permission to conduct a clinical trial of a biomedical cell product and ethical examination, examination of the effectiveness of a biomedical cell product and examination of the ratio of the expected benefit to the possible risk of using a biomedical cell product, in relation to which conducted international multicenter clinical studies, some of which were conducted in the Russian Federation, when applying for state registration of a biomedical cell product. In case of failure to submit the specified documents, the authorized federal executive body verifies the fact of payment of the state duty on the basis of the details of documents submitted by the applicant confirming its payment, using information on the payment of the state duty contained in the State Duty information system on state and municipal payments.

4. It is not permitted to use for commercial purposes information on the results of preclinical studies of biomedical cell products and clinical studies of biomedical cell products, submitted by the applicant for state registration of a biomedical cell product, without his consent for six years from the date of state registration of the biomedical cell product in the Russian Federation.

Article 10. Decision on issuing tasks to an expert institution and an ethics council to conduct examinations of a biomedical cell product

1. Within five working days from the date of acceptance of the application for state registration of a biomedical cell product, the authorized federal executive body shall verify the completeness and accuracy of the information contained in the documents submitted by the applicant and make a decision to issue an assignment to carry out:

1) biomedical examination of a biomedical cell product in terms of examination of the quality of a biomedical cell product, examination of documents for obtaining permission to conduct a clinical trial of a biomedical cell product and ethical examination on the basis of documents specified in paragraphs 1 - 11, 13 of part 2 of Article 9 of this Federal Law;

2) biomedical examination of a biomedical cell product in terms of examination of the effectiveness of a biomedical cell product and examination of the ratio of the expected benefit to the possible risk of using a biomedical cell product, in respect of which international multicenter clinical trials have been conducted, some of which were conducted in the Russian Federation, on the basis of the documents specified in paragraphs 1 - 6, 8, 9, 12 and 13 of part 2 of article 9 of this Federal Law.

2. The authorized federal executive body notifies the applicant in writing about the decision taken, and in case of refusal to organize the examinations specified in part 1 of this article - indicating the reasons for such refusal.

3. If information contained in the documents submitted by the applicant is revealed to be incomplete or unreliable, the authorized federal executive body sends the applicant a request to clarify this information, which can be transferred to the authorized representative of the applicant personally against signature, sent by registered mail or transmitted electronically via telecommunication channels. If this request is sent by registered mail, it is considered received after six days from the date of sending the registered letter.

4. The applicant is obliged to submit a response to the request of the authorized federal executive body specified in Part 3 of this article within a period not exceeding ninety working days from the date of its receipt. The period specified in Part 1 of this article is suspended from the day the request is sent to the applicant by the authorized federal executive body until the day it receives the corresponding response.

5. The basis for refusal to organize the examinations provided for in Part 1 of this article is the submission of the necessary documents incompletely, the applicant’s failure to provide a response within the prescribed period to the request of the authorized federal executive body specified in Part 3 of this article, or the absence of an exhaustive list in the submitted documents necessary information, which should be reflected in them, as well as the lack of information confirming the fact of payment of the state fee for conducting an examination of the quality of a biomedical cell product, examination of documents for obtaining permission to conduct a clinical trial of a biomedical cell product, ethical examination, examination of the effectiveness of a biomedical cell product and examination of attitude expected benefit to the possible risk of using a biomedical cell product, for which international multicenter clinical trials have been conducted, some of which were conducted in the Russian Federation, when applying for state registration of a biomedical cell product.

Article 11. Federal state budgetary institution for conducting biomedical examination of biomedical cell products

1. Biomedical examination of biomedical cell products is carried out by a federal state budgetary institution, which is under the authority of the authorized federal executive body and ensures the execution of the powers of this federal executive body to issue permits to conduct clinical trials of biomedical cell products and (or) state registration of biomedical cell products ( hereinafter - expert institution).

2. The expert institution provides advice on issues related to the conduct of preclinical studies of biomedical cell products, clinical studies of biomedical cell products, biomedical examination of biomedical cell products, state registration of biomedical cell products, in the manner approved by the authorized federal executive body.

Article 12. Organization of biomedical examination of a biomedical cell product

1. Biomedical examination of a biomedical cell product is carried out in two stages:

1) at the first stage, an examination of the quality of a biomedical cell product and an examination of documents are carried out to obtain permission to conduct a clinical trial of a biomedical cell product, with the exception of a biomedical cell product for which international multicenter clinical trials have been conducted, some of which were conducted in the Russian Federation;

2) at the second stage, an examination of the effectiveness of using a biomedical cell product and an examination of the ratio of the expected benefit to the possible risk of using a biomedical cell product are carried out. These examinations are carried out based on the results of clinical studies of a biomedical cell product.

2. Biomedical examination of a biomedical cellular product is carried out by a commission of experts of an expert institution, appointed by the head of this institution, on the basis of an assignment from the authorized federal executive body to conduct a biomedical examination of a biomedical cellular product. The head of the expert institution ensures the proper conduct of biomedical examination of the biomedical cell product in accordance with the assignment of the authorized federal executive body and organizes the preparation of a summary conclusion of the expert commission of the expert institution.

3. At the request of the expert and based on the decision of the head of the expert institution, other persons may be included as experts in the commission of experts, including those not working in this expert institution, if their special knowledge is necessary to carry out the examination of a biomedical cell product.

4. When conducting a biomedical examination of a biomedical cell product, the expert cannot be in any way dependent on the applicant, the person who appointed this examination, or other persons interested in the results of the biomedical examination of the biomedical cell product.

5. When conducting a biomedical examination of a biomedical cell product, the expert does not have the right to independently request from the applicant documents and (or) materials necessary for the examination. If the documents and (or) materials provided to the expert are insufficient to provide an opinion, the expert has the right to raise the issue of providing him with the necessary documents and (or) materials before the head of the expert institution, who makes a corresponding request to the authorized federal executive body that issued the assignment to conduct the biomedical examination. examination of biomedical cell product. The authorized federal executive body, within five working days from the date of receipt of the request from the head of the expert institution, sends an electronic or written request to the applicant for additional documents and (or) materials with notification of its receipt. The applicant is obliged, within a period not exceeding sixty working days from the date of receipt of the request from the authorized federal executive body, to submit the requested documents and (or) materials or to justify the impossibility of submitting them. The time from the date the request is sent until the authorized federal executive body receives the applicant’s response to the request is not taken into account when calculating the period for state registration of a biomedical cell product.

6. The results of each stage of biomedical examination of a biomedical cell product are formalized by the conclusion of a commission of experts of an expert institution. The conclusion of the commission of experts of the expert institution indicates a list of studies, the scope of studies carried out by each expert, the facts established by each of them and the conclusions drawn as a result of the studies. An expert whose opinion does not coincide with the decision of the commission of experts of an expert institution has the right to express his opinion in writing, which is attached to the conclusion of the commission of experts.

7. The rules for conducting biomedical examination of biomedical cell products and the forms of conclusions of the commission of experts of the expert institution are established by the authorized federal executive body.

8. The expert institution is responsible for compliance with the rules for conducting biomedical examination of a biomedical cell product and for the quality of its implementation.

Article 13. Requirements for experts when conducting biomedical examination of biomedical cell products, rights and responsibilities of experts

1. An expert in conducting biomedical examination of biomedical cell products is a certified employee of an expert institution who has a higher medical, pharmaceutical, veterinary, biological or chemical education and conducts biomedical examination of biomedical cell products in the performance of his official duties.

2. Requirements for the professional training of experts and work experience in their specialty, the procedure for certification of experts, the procedure for the formation and activities of qualification commissions are established by the authorized federal executive body.

3. Certification of experts for the right to conduct biomedical examination of biomedical cell products is carried out by qualification commissions of the authorized federal executive body at least once every five years.

4. When conducting a biomedical examination of biomedical cell products, the expert is obliged to:

1) conduct a study of research objects, documents and (or) materials presented to him, evaluate the proposed methods for quality control of a biomedical cell product, give an opinion on the questions posed to him with appropriate justification or a conclusion on the impossibility of conducting a biomedical examination of biomedical cell products, if the questions raised questions go beyond special knowledge an expert or if research objects, documents and (or) materials are unsuitable or insufficient for conducting research and giving an opinion;

2) ensure proper storage of submitted research objects, documents and (or) materials.

5. The expert has no right:

1) conduct biomedical examination of biomedical cell products upon application directly to him by legal entities or individuals;

2) independently collect materials for conducting biomedical examination of biomedical cell products;

3) provide consultations in the field of professional activities outside of official assignments;

4) disclose information that became known to him in connection with the biomedical examination of biomedical cell products, as well as information constituting a state, commercial or other secret protected by law.

6. Each expert who is part of the commission of experts of an expert institution, which is entrusted with conducting biomedical examination of biomedical cell products, independently and independently conducts research, evaluates the results obtained by him personally and other experts, and formulates conclusions regarding the questions posed within the limits of his special knowledge.

Article 14. Ethical review

1. Ethical examination is carried out by an ethics council established in the manner established by the authorized federal executive body in order to issue an opinion on the ethical validity of the possibility of conducting a clinical trial of a biomedical cell product.

2. Experts of the ethics council may be representatives of medical organizations, scientific organizations, educational organizations of higher education, educational organizations of additional professional education, as well as representatives of public organizations, religious organizations and the media. These experts should not be in any way dependent on the applicant and other persons interested in the results of the ethical examination.

3. Payment for the services of ethics council experts is carried out on the basis of an agreement concluded between the authorized federal executive body that created the ethics council and the ethics council expert, at the expense of budgetary allocations provided for the authorized federal executive body that created the ethics council, in the federal budget for the corresponding year to ensure its activities, in the amounts established by the Government of the Russian Federation.

4. Ethics council experts bear responsibility in accordance with the legislation of the Russian Federation.

5. The composition of the ethics council, regulations on this council, the procedure for its activities, requirements for qualifications and work experience in expert assessment scientific, medical and ethical aspects of clinical trials of biomedical cell products, requirements for ethics council experts, the procedure for organizing and conducting ethical examination, and the form of the ethics council's conclusion are established by the authorized federal executive body. The number of representatives of medical organizations and scientific organizations cannot exceed half of total number ethics council experts.

6. Information about the composition of the ethics council, its work plans and current activities is posted on the official website of the authorized federal executive body on the Internet information and telecommunications network (hereinafter referred to as the Internet) in the manner established by it.

7. Ethical examination, drawing up conclusions by the ethics council on the possibility or impossibility of conducting a clinical trial of a biomedical cell product and sending these conclusions to the authorized federal executive body are carried out within a period not exceeding thirty working days from the date the ethics council receives the assignment from the authorized federal executive body authorities and the necessary documents specified in paragraphs 1 - 11, 13 of part 2 of article 9 of this Federal Law.

8. Documents contained in the registration dossier and received by the ethics council for ethical examination in order to obtain permission to conduct a clinical trial of a biomedical cell product must be returned to the authorized federal executive body.

Article 15. Examination of the quality of a biomedical cell product and examination of documents for obtaining permission to conduct a clinical trial of a biomedical cell product

1. Examination of the quality of a biomedical cell product, examination of documents for obtaining permission to conduct a clinical trial of a biomedical cell product, drawing up a conclusion by a commission of experts of an expert institution on confirmation of the quality of a biomedical cell product and the possibility of conducting its clinical trial or on non-confirmation of the quality of a biomedical cell product and the impossibility of conducting it clinical trial, sending the corresponding conclusion to the authorized federal executive body is carried out within a period not exceeding one hundred working days from the date the expert institution receives the assignment from the authorized federal executive body with the attachment of the necessary documents specified in paragraphs 1 - 11, 13 of part 2 of article 9 of this Federal Law.

2. Within sixty working days from the date the applicant receives from the expert institution a notification that the specified expert institution has received an assignment from the authorized federal executive body specified in Part 1 of this article, the applicant submits samples of the biomedical cell product to the expert institution for examination of the quality of the biomedical cell product , cell line (cell lines), medical devices, drugs, substances included in the composition of a biomedical cellular product, used in the examination of the quality of a biomedical cellular product by comparing the studied biomedical cellular product with them, in the amount necessary to reproduce the methods of quality control of the biomedical cell product, in the manner established by the authorized federal executive body.

3. Upon receipt of samples of a biomedical cell product and other samples specified in part 2 of this article, the expert institution issues the applicant a document confirming receipt of the specified samples, and within a period not exceeding three working days from the date of receipt of the specified samples, notifies the authorized federal executive authority.

4. If the declared shelf life of a biomedical cell product is less than fifteen days, an examination of the quality of the biomedical cell product is carried out in the manner established by the authorized federal executive body, a commission of experts of an expert institution at the place of production of the biomedical cell product using the manufacturer’s equipment, while the applicant, within sixty working days from the date of receipt from the expert institution specified in part 1 of this article of notification of receipt of the assignment from the authorized federal executive body, notifies the expert institution of its readiness to conduct an examination of the quality of the biomedical cell product at the place of production of the biomedical cell product.

5. The period specified in parts 2 and 3 of this article for the applicant to submit samples of a biomedical cell product and other samples and the period for notification by the expert institution of this to the authorized federal executive body are not included in the period for conducting examinations provided for in part 1 of this article.

6. An expert institution, from samples of a cell line (cell lines) submitted for examination of the quality of a biomedical cell product, compiles a collection of permanent storage of samples of standardized cell lines, the formation, use, storage, accounting and destruction of which are carried out in the manner established by the authorized federal executive body .

7. The documents contained in the registration dossier and received by the expert institution for conducting the appropriate examinations in order to obtain permission to conduct a clinical trial of a biomedical cell product must be returned to the authorized federal executive body simultaneously with the conclusion based on the results of these examinations.

Article 16. Obtaining and evaluating conclusions based on the results of examinations carried out for the purpose of issuing permission to conduct a clinical trial of a biomedical cell product

1. Within a period not exceeding five working days from the date of receipt of the conclusion of the commission of experts of the expert institution specified in Part 1 of Article 15 of this Federal Law, and the conclusion of the ethics council specified in Part 7 of Article 14 of this Federal Law, the authorized federal executive body evaluates the received conclusions to determine their compliance with the tasks for conducting the relevant examinations and notifies the applicant in writing about the conclusions presented based on the results of the examinations.

2. Upon receipt of the conclusion of a commission of experts of an expert institution on confirmation of the quality of a biomedical cell product and the possibility of conducting its clinical trial and the conclusion of the ethics council on the possibility of conducting a clinical trial of a biomedical cell product, the authorized federal executive body shall suspend the state registration of the biomedical cell product until the applicant submits it to authorized federal executive body application for renewal of state registration of a biomedical cell product.

3. Upon receipt of the conclusion of a commission of experts of an expert institution on the non-confirmation of the quality of a biomedical cell product and the impossibility of conducting its clinical trial or the conclusion of the ethics council on the impossibility of conducting a clinical trial of a biomedical cell product, the authorized federal executive body makes a decision to terminate the state registration of the biomedical cell product and notifies about this in writing by the applicant.

Article 17. Decision to grant permission to conduct a clinical trial of a biomedical cell product

1. To obtain permission to conduct a clinical trial of a biomedical cell product, the applicant, who has received, in accordance with Part 1 of Article 16 of this Federal Law, a notification of the issuance, based on the results of the examinations specified in paragraph 1 of Part 1 of Article 12 of this Federal Law, of the conclusion of a commission of experts of an expert institution on confirmation of the quality of the biomedical cell product and the possibility of conducting its clinical trial and the conclusion of the ethics council on the possibility of conducting a clinical trial of the biomedical cell product, submits to the authorized federal executive body:

1) application for permission to conduct a clinical trial of a biomedical cell product;

2) an investigator's brochure, which is a summary of the results of the preclinical study of the biomedical cell product and the clinical study of the biomedical cell product;

3) information about the work experience of researchers in relevant specialties and their experience in conducting clinical studies of biomedical cell products;

4) a copy of the compulsory life insurance agreement, the health of a patient participating in a clinical trial of a biomedical cell product (hereinafter referred to as the compulsory insurance agreement), which is concluded in accordance with the standard rules of compulsory life insurance, health of a patient participating in a clinical trial of a biomedical cell product, approved by the Government of the Russian Federation (hereinafter referred to as the standard rules of compulsory insurance), indicating information about the maximum number of patients participating in a clinical trial of a biomedical cell product;

5) information about medical organizations in which it is planned to conduct a clinical trial of a biomedical cell product (full and abbreviated names, organizational and legal form, location, place of activity, telephone, fax, e-mail address, information about accreditation for the right to conduct clinical trials biomedical cell products of each medical organization);

6) information on the expected timing of the clinical trial of the biomedical cell product;

7) details of the document confirming payment of the state fee for issuing permission to conduct a clinical trial of a biomedical cell product.

2. Within a period not exceeding five working days from the date of acceptance of the application and documents specified in Part 1 of this article, the authorized federal executive body:

2) decides to issue a permit to conduct a clinical trial of a biomedical cell product or to refuse to issue the said permit;

3) notifies the applicant in writing about the decision made (in the case of a decision to refuse, indicating the reasons for such refusal);

4) issues permission to conduct a clinical trial of a biomedical cell product in the manner established by the authorized federal executive body.

3. If information contained in the documents submitted by the applicant is identified as incomplete or unreliable, the authorized federal executive body sends the applicant a request to clarify the specified information. This request can be submitted to the authorized representative of the applicant in person against signature, sent by registered mail or transmitted electronically via telecommunication channels. If this request is sent by registered mail, it is considered received after six days from the date of sending the registered letter.

4. The applicant is obliged to submit a response to the request of the authorized federal executive body specified in Part 3 of this article within a period not exceeding ninety working days from the date of receipt of this request. The period specified in Part 2 of this article is suspended from the day the request is sent to the applicant by the authorized federal executive body until the day it receives a response to this request.

5. The grounds for refusal to issue permission to conduct a clinical trial of a biomedical cell product are failure to provide in full the documents specified in Part 1 of this article, failure by the applicant to provide a response within the established time limit to the request of the authorized federal executive body specified in Part 3 of this article, or discrepancy between the content of the documents submitted by the applicant and the requirements of this Federal Law.

Article 18. Examination of the effectiveness of a biomedical cell product and examination of the relationship between the expected benefit and the possible risk of using a biomedical cell product

1. Examination of the effectiveness of a biomedical cell product and examination of the ratio of the expected benefit to the possible risk of using a biomedical cell product, drawing up conclusions on their results by a commission of experts of an expert institution and sending these conclusions to the authorized federal executive body are carried out within a period not exceeding twenty-five working days from the day the expert institution receives the corresponding assignment from the authorized federal executive body with the documents specified in paragraphs 1 - 5, 13 of part 2 of Article 9 of this Federal Law, and a report on the clinical study of the biomedical cell product.

2. To conduct the examinations specified in Part 1 of this article, the applicant submits to the authorized federal executive body:

1) an application for renewal of state registration of a biomedical cell product and carrying out the examinations specified in part 1 of this article;

2) draft layouts of primary packaging and secondary packaging of a biomedical cellular product, if necessary, modified based on the results of a clinical trial of a biomedical cellular product;

3) a report on a clinical study of a biomedical cell product;

4) draft instructions for use of the biomedical cell product, if necessary, modified based on the results of a clinical trial of the biomedical cell product;

5) details of documents confirming payment of the state fee for conducting an examination of the effectiveness of a biomedical cell product and an examination of the ratio of the expected benefit to the possible risk of using a biomedical cell product during state registration of a biomedical cell product. The applicant has the right to submit the specified documents on his own initiative. If they are not submitted, the authorized federal executive body verifies the fact of payment of the state duty on the basis of the details of documents submitted by the applicant confirming its payment, using information on the payment of the state duty contained in the State Information System on State and Municipal Payments.

3. Within a period not exceeding five working days from the date of acceptance of the application for renewal of state registration of a biomedical cell product with the documents specified in parts 1 and 2 of this article, the authorized federal executive body:

1) checks the completeness and accuracy of the data contained in the report on the clinical trial of the biomedical cell product submitted by the applicant;

2) decides to renew the state registration of a biomedical cell product and conduct the examinations specified in Part 1 of this article or to refuse to renew the state registration of a biomedical cell product and conduct the specified examinations;

3) notifies the applicant in writing about the decision made (if a decision is made to refuse, indicating the reasons for such refusal).

4. If information contained in the documents submitted by the applicant is identified as incomplete or unreliable, the authorized federal executive body sends the applicant a request to clarify the specified information. This request can be submitted to the authorized representative of the applicant in person against signature, sent by registered mail or transmitted electronically via telecommunication channels. If this request is sent by registered mail, it is considered received after six days from the date of sending the registered letter.

5. The applicant is obliged to submit a response to the request of the authorized federal executive body specified in Part 4 of this article within a period not exceeding ninety working days from the date of receipt of this request. The period specified in Part 3 of this article is suspended from the day the request is sent to the applicant by the authorized federal executive body until the day it receives a response to this request.

6. The basis for refusal to renew the state registration of a biomedical cell product and conduct the examinations specified in part 1 of this article is the submission of the documents specified in parts 1 and 2 of this article in incomplete quantities, the applicant’s failure to submit a response to the response specified in part 4 of this article within the established time limit. article a request from an authorized federal executive body or the absence in the submitted documents of an exhaustive list of necessary information that should be reflected in them, as well as the absence of information confirming the fact of payment of the state fee for conducting an examination of the effectiveness of a biomedical cell product and an examination of the ratio of the expected benefit to the possible risk of use biomedical cell product upon state registration of the biomedical cell product.

7. Examination of the effectiveness of a biomedical cell product and examination of the ratio of the expected benefit to the possible risk of using a biomedical cell product, in respect of which international multicenter clinical trials have been conducted, some of which were conducted in the Russian Federation, are carried out on the basis of the documents specified in paragraphs 1 - 6, 8 , 9, 12 and 13 of part 2 of article 9 of this Federal Law, within the period specified in part 1 of this article.

Article 19. Repeated biomedical examination of a biomedical cell product and (or) ethical examination

1. If the conclusion of a commission of experts of an expert institution or an ethics council contains contradictory data, unfounded and (or) incomplete conclusions, falsification of the conclusions of a biomedical examination of a biomedical cell product and (or) ethical examination, concealment from the authorized federal executive body of the grounds for recusal expert due to his interest in the results of the relevant examination, the presence of data on direct or indirect interference in the process of the relevant examination of persons not participating in its conduct, but who influenced the process and results of its conduct, the authorized federal executive body appoints a repeated biomedical examination of the biomedical cellular product and/or re-ethical review. The scope of the re-examination is determined by the authorized federal executive body.

2. Repeated biomedical examination of a biomedical cell product is carried out within the period established by the authorized federal executive body and not exceeding one hundred working days from the date the expert institution received the task to conduct a repeated biomedical examination of the biomedical cell product, and repeated ethical examination - within a period not exceeding fifteen working days from the date of receipt by the ethics council of the assignment to conduct a repeat ethical examination.

3. Experts of the commission of an expert institution and members of the ethics council in respect of whom the circumstances specified in part 1 of this article have been established are not allowed to conduct repeated examinations.

4. Financial support for the repeated biomedical examination of a biomedical cell product is carried out at the expense of funds received by the expert institution from income-generating activities.

Article 20. Decision on state registration of a biomedical cell product

1. Within a period not exceeding five working days from the date of receipt of the conclusions of a commission of experts of an expert institution based on the results of an examination of the effectiveness of a biomedical cell product and an examination of the ratio of the expected benefit to the possible risk of using a biomedical cell product, the authorized federal executive body:

1) evaluates the received conclusions based on the results of the specified examinations to determine the compliance of these conclusions with the assignment for conducting the specified examinations;

2) makes a decision on state registration of a biomedical cellular product or on refusal of state registration of a biomedical cellular product;

3) when making a decision on state registration of a biomedical cell product, enters data on the registered biomedical cell product into the state register of biomedical cell products and issues to the applicant a registration certificate of a biomedical cell product, the form of which is approved by the authorized federal executive body, the agreed specification for the biomedical cell product, instructions on the use of a biomedical cell product, regulatory documentation for a biomedical cell product, or in the event of a decision to refuse state registration of a biomedical cell product, notifies the applicant in writing, indicating the reasons for such refusal.

2. The basis for the decision by the authorized federal executive body to refuse state registration of a biomedical cell product is the conclusion of a commission of experts of an expert institution, based on the results of the examinations specified in Part 1 of Article 18 of this Federal Law, that the effectiveness of the registered biomedical cell product is not is confirmed by the data obtained or the risk of harm to human health due to the use of a biomedical cell product exceeds the effectiveness of its use.

Article 21. Registration certificate biomedical cell product

1. A registration certificate of a biomedical cell product for a biomedical cell product registered for the first time in the Russian Federation is issued with a validity period of five years.

2. After the expiration of the period specified in part 1 of this article, the validity period of the registration certificate of a biomedical cell product is extended every five years, subject to confirmation of its state registration.

3. If, in accordance with Article 23 of this Federal Law, changes are made to the documents contained in the registration dossier for a registered biomedical cell product, affecting the information reflected in the registration certificate of the biomedical cell product, the authorized federal executive body issues a new registration certificate of the biomedical cell product product subject to changes.

4. For the issuance of a registration certificate for a biomedical cell product, a state duty is charged in the amount and manner established by the legislation of the Russian Federation on taxes and fees.

5. The organization in whose name the registration certificate for a biomedical cell product was issued is the owner of the registration certificate for the biomedical cell product.

6. In the event of loss or damage to the registration certificate of a biomedical cell product, upon a written application from the owner of the registration certificate of a biomedical cell product or a person authorized by him to issue a duplicate of the registration certificate of a biomedical cell product, the authorized federal executive body within a period not exceeding ten working days from the date of receipt of such application, issues a duplicate of the registration certificate of the biomedical cell product. For the issuance of a duplicate registration certificate of a biomedical cell product in connection with the loss or damage of this registration certificate, a state fee is charged in the amount and manner established by the legislation of the Russian Federation on taxes and fees.

Article 22. Confirmation of state registration of a biomedical cell product

1. Confirmation of state registration of a biomedical cell product is carried out when issuing a registration certificate for a biomedical cell product in the case specified in Part 2 of Article 21 of this Federal Law, within a period not exceeding ninety working days from the date of receipt by the authorized federal executive body of the application for confirmation of state registration biomedical cellular product indicating the details of the document confirming payment of the state fee for confirmation of state registration of the biomedical cellular product.

2. Confirmation of state registration of a biomedical cell product is carried out based on the results of an examination of the ratio of the expected benefit to the possible risk of using a biomedical cell product, carried out on the basis of data from monitoring the safety of the biomedical cell product, carried out by the owner of the registration certificate of the biomedical cell product and the federal executive body exercising control functions and supervision in the field of healthcare, in accordance with Article 41 of this Federal Law, as well as examination of the quality of a biomedical cell product, carried out in the event of changes to the regulatory documentation for a biomedical cell product.

3. Attached to the application for confirmation of state registration of a biomedical cellular product is a document containing the results of monitoring the safety of the biomedical cellular product carried out by the owner of the registration certificate of the biomedical cellular product, in the form established by the authorized federal executive body, and a copy of the license to carry out activities for the production of biomedical cellular products products.

4. Regulatory documentation for a biomedical cell product, draft instructions for use of a biomedical cell product, draft layouts of primary packaging and secondary packaging of a biomedical cell product are attached to the application for confirmation of state registration of a biomedical cell product only if changes are made to them.

5. With an application for confirmation of state registration of a biomedical cell product, the owner of the registration certificate of a biomedical cell product has the right, on his own initiative, to submit a document confirming payment of the state fee for confirmation of state registration of a biomedical cell product. In case of failure to submit the specified document, the authorized federal executive body, based on the details of the specified document submitted by the owner of the registration certificate of the biomedical cell product, verifies the fact of payment of the state duty using information on the payment of state duties contained in the State Information System on State and Municipal Payments.

6. Within ten working days from the date of acceptance of the application for confirmation of state registration of a biomedical cell product and the documents specified in Part 3 of this article, the authorized federal executive body:

1) checks the completeness and accuracy of the information contained in the documents submitted by the applicant;

2) sends to the federal executive body exercising the functions of control and supervision in the field of healthcare a request to present the results of monitoring the safety of a biomedical cell product, which must be executed within five working days from the date of its receipt;

3) decides to conduct or refuse to conduct an examination of the relationship between the expected benefit and the possible risk of using a biomedical cell product, as well as an examination of the quality of a biomedical cell product, carried out in the event of changes to the regulatory documentation for a biomedical cell product;

4) notifies in writing the owner of the registration certificate of the biomedical cell product about the decision made (if a decision is made to refuse to conduct the relevant examination, indicating the reasons for such refusal).

7. If information contained in the documents submitted by the owner of the registration certificate of a biomedical cell product is identified, the authorized federal executive body sends the owner of the registration certificate of the biomedical cell product a request to clarify the specified information. This request can be submitted to the authorized representative of the holder of the registration certificate of the biomedical cell product in person against signature, sent by registered mail or transmitted electronically via telecommunication channels. If this request is sent by registered mail, it is considered received after six days from the date of sending the registered letter.

8. The owner of the registration certificate of a biomedical cell product is obliged to submit a response to the request of the authorized federal executive body specified in Part 7 of this article within a period not exceeding ninety working days from the date of receipt of this request. The period specified in Part 6 of this article is suspended from the day the authorized federal executive body sends a request to the owner of the registration certificate of a biomedical cell product until the day it receives a response to this request and is not taken into account when calculating the period for confirming the state registration of a biomedical cell product.

9. The basis for refusal to conduct an examination of the relationship between the expected benefit and the possible risk of using a biomedical cell product and (or) an examination of the quality of a biomedical cell product is the submission of the documents specified in parts 1, 3 and 4 of this article in incomplete volume, failure to submit within the prescribed period a response to the request of the authorized federal executive body specified in Part 7 of this article or the absence in the submitted documents of comprehensive information that should be reflected in them, as well as the absence of information confirming the payment of the state fee for confirming the state registration of the biomedical cell product.

10. An examination of the ratio of the expected benefit to the possible risk of using a biomedical cell product and (or) an examination of the quality of a biomedical cell product is carried out on the basis of the documents specified in parts 3, 4 and paragraph 2 of part 6 of this article, in the manner established by articles 15 and 18 of this article Federal Law, taking into account the period specified in Part 1 of this article.

11. The basis for a decision to refuse confirmation of state registration of a biomedical cell product is the conclusion of a commission of experts of an expert institution, based on the results of the examinations specified in Part 2 of this article, that the quality and (or) effectiveness of the biomedical cell product is not confirmed by the data obtained and/or the risk of harm to human health resulting from the use of the biomedical cell product exceeds its effectiveness.

12. During the period of the procedure for confirming the state registration of a biomedical cell product, its circulation in the Russian Federation continues.

Article 23. Amendments to the documents contained in the registration dossier for a registered biomedical cell product

1. In order to make changes to the documents contained in the registration dossier for a registered biomedical cell product, the owner of the registration certificate of the biomedical cell product submits to the authorized federal executive body an application for making such changes in the form established by the authorized federal executive body and attached to him changes to the specified documents, as well as documents confirming the need to make such changes.

2. Biomedical examination of a biomedical cell product in terms of examination of the quality of a biomedical cell product, and (or) examination of the effectiveness of a biomedical cell product, and (or) examination of the ratio of the expected benefit to the possible risk of using a biomedical cell product is carried out in the event of changes to the documents contained in registration dossier for a registered biomedical cell product, in relation to:

1) information specified in the instructions for use of the biomedical cell product and provided for in subparagraphs “e” - “p” of paragraph 13 of part 2 of article 9 of this Federal Law;

2) places of production of the biomedical cell product;

3) quality indicators and (or) methods for quality control of a biomedical cell product contained in the regulatory documentation for a biomedical cell product;

4) shelf life of the biomedical cell product.

3. The owner of the registration certificate of a biomedical cell product, along with the application and documents specified in part 1 of this article, submits details of a document confirming payment of the state fee for making changes to the documents contained in the registration dossier for a registered biomedical cell product that require a biomedical examination biomedical cellular product, or details of a document confirming payment of the state fee for making changes to the documents contained in the registration dossier for a registered biomedical cellular product that do not require a biomedical examination of the biomedical cellular product, or has the right to submit these documents on its own initiative. If the owner of the registration certificate of a biomedical cell product fails to provide the specified documents, the authorized federal executive body verifies the fact of payment of the state duty based on the details of the document confirming its payment, using information on the payment of state duties contained in the State Information System on State and Municipal Payments.

4. Within five working days from the date of receipt of the application and documents specified in Part 1 of this article, the authorized federal executive body:

1) checks the completeness and accuracy of the information contained in the documents submitted by the owner of the registration certificate of the biomedical cell product;

2) decides to carry out the relevant examinations of the biomedical cell product specified in Part 2 of this article or to refuse to carry them out;

3) notifies in writing the owner of the registration certificate of the biomedical cell product about the decision made (if a decision is made to refuse to conduct the relevant examination, indicating the reasons for such refusal).

5. If information contained in the documents submitted by the owner of the registration certificate of a biomedical cell product is identified, the authorized federal executive body sends the owner of the registration certificate of the biomedical cell product a request to clarify the specified information. This request can be submitted to the authorized representative of the holder of the registration certificate of the biomedical cell product in person against signature, sent by registered mail or transmitted electronically via telecommunication channels. If this request is sent by registered mail, it is considered received after six days from the date of sending the registered letter.

6. The owner of the registration certificate of a biomedical cell product is obliged to submit a response to the request of the authorized federal executive body within a period not exceeding ninety working days from the date of receipt of this request. The period specified in part 4 of this article is suspended from the day the authorized federal executive body sends a request to the owner of the registration certificate of a biomedical cell product until the day it receives a response to this request and is not taken into account when calculating the period for making a decision to amend the documents contained in the registration dossier for a registered biomedical cell product.

7. The examinations specified in Part 2 of this article are carried out in the manner established by Articles 15 and 18 of this Federal Law, taking into account the period specified in Part 10 of this article.

8. Within a period not exceeding five working days from the date of receipt of the conclusions of the commission of experts of the expert institution based on the results of the examinations specified in Part 2 of this article in relation to the proposed changes, the authorized federal executive body:

1) evaluates the received conclusions of the commission of experts of the expert institution to determine their compliance with the tasks for conducting the relevant examinations;

2) decides to make changes to the documents contained in the registration dossier for a registered biomedical cell product, or to refuse to make such changes;

3) enters into the state register of biomedical cell products, on the basis of a decision to amend the documents contained in the registration dossier for a registered biomedical cell product, the necessary changes;

4) issues a new registration certificate for a biomedical cell product if the information contained in it changes, while the previously issued registration certificate is withdrawn.

9. The basis for the decision by the authorized federal body to refuse to make changes to the documents contained in the registration dossier for a registered biomedical cell product is the conclusion of a commission of experts of an expert institution, based on the results of the examinations specified in Part 2 of this article, that in If such changes are made, the quality and (or) effectiveness of the biomedical cell product may decrease and (or) the risk of harm to human health due to the use of the biomedical cell product may exceed its effectiveness.

10. If changes are made to the documents contained in the registration dossier for a registered biomedical cell product, as specified in Part 2 of this article, a decision is made to make such changes (including making corresponding changes to the state register of biomedical cell products) or to refuse them introduction is carried out within a period not exceeding ninety working days from the date of acceptance by the authorized federal executive body of the application for making such changes.

11. Making a decision to make changes (including making appropriate changes to the state register of biomedical cell products) or to refuse to include them in the documents contained in the registration dossier for a registered biomedical cell product, in relation to information that does not require examinations specified in part 2 of this article is carried out within a period not exceeding thirty working days from the date of acceptance by the authorized federal executive body of the application for making such changes.

12. Circulation of a biomedical cell product produced before the date of adoption by the authorized federal executive body of the decision to amend the documents contained in the registration dossier for the registered biomedical cell product, as well as produced within one hundred and eighty calendar days after the date of adoption by the authorized federal executive body of the specified decision is allowed until its expiration date.

Article 24. Cancellation of state registration of a biomedical cell product

The decision to cancel the state registration of a biomedical cell product and exclude the biomedical cell product from the state register of biomedical cell products is made by the authorized federal executive body in the following cases:

1) submission by the federal executive body exercising the functions of control and supervision in the field of healthcare of a conclusion on the risk or threat to human health or life when using a biomedical cell product that exceeds its effectiveness, based on the results of its monitoring of the safety of the biomedical cell product;

2) submission by the owner of the registration certificate of the biomedical cellular product of an application to cancel the state registration of the biomedical cellular product;

3) the decision by the authorized federal executive body to refuse to confirm the state registration of a biomedical cell product upon expiration of the registration certificate of the biomedical cell product;

4) failure by the applicant to provide information that may entail the need to make changes in the registration dossier for a registered biomedical cell product specified in Part 2 of Article 23 of this Federal Law within thirty working days from the date of such changes;

5) the court makes a decision on violation of the rights of the copyright holder to the results of intellectual activity during the circulation of biomedical cellular products.

Article 25. State Register of Biomedical Cell Products

1. The state register of biomedical cell products is maintained by the authorized federal executive body.

2. The State Register of Biomedical Cell Products contains a list of biomedical cell products that have passed state registration and the following information:

1) name of the biomedical cell product;

2) type of biomedical cell product (autologous, allogeneic, combined);

3) the name of the owner of the registration certificate of the biomedical cell product;

4) name and address of the manufacturer of the biomedical cell product;

5) code designation of the cell line (cell lines) included in the biomedical cell product;

6) names (international non-proprietary, or group, or chemical) of medicinal products included in the biomedical cellular product, number of regulatory documentation;

7) names of medical devices included in the biomedical cellular product, name and number of regulatory documentation;

8) shelf life of the biomedical cell product;

9) storage conditions of the biomedical cell product;

10) indications and contraindications for the use of a biomedical cell product;

11) side effects of the biomedical cell product;

12) date of state registration of the biomedical cell product and its registration number;

13) date of replacement of the registration certificate of the biomedical cell product, date of confirmation of the state registration of the biomedical cell product, date of cancellation of the state registration of the biomedical cell product.

3. The procedure for maintaining the state register of biomedical cell products is approved by the authorized federal executive body.

Article 26. Appeal of a decision to refuse permission to conduct a clinical trial of a biomedical cell product or a decision to refuse state registration of a biomedical cell product

The decision of the authorized federal executive body to refuse to issue permission to conduct a clinical trial of a biomedical cell product or the decision to refuse state registration of a biomedical cell product, the conclusion of a commission of experts of an expert institution or the conclusion of the ethics council may be appealed in the manner established by the legislation of the Russian Federation.

Article 27. Information related to the state registration of a biomedical cell product, information on registered biomedical cell products and biomedical cell products excluded from the state register of biomedical cell products

1. The authorized federal executive body shall place on its official website on the Internet information related to the state registration of biomedical cell products, including the conduct of biomedical examination of biomedical cell products and ethical examination, information on registered biomedical cell products and biomedical cell products excluded from the state register of biomedical cell products no later than five working days from the date of receipt by the authorized federal executive body of an application for state registration of a biomedical cell product.

2. The procedure for posting the information specified in Part 1 of this article is established by the authorized federal executive body.

Article 28. Organization of clinical trials of biomedical cell products

1. The organization of clinical trials of biomedical cell products has the right to be carried out by an organization that has rights to the results of preclinical studies of a biomedical cell product, clinical studies of a biomedical cell product and (or) the production technology of a biomedical cell product, or an authorized legal entity, an educational organization of higher education, educational organization of additional professional education, scientific organization.

2. The organizations specified in part 1 of this article may involve other legal entities in organizing clinical trials of biomedical cell products, regardless of their legal form and form of ownership.

3. Financial support for conducting a clinical trial of a biomedical cell product is provided through:

1) budgetary allocations of the federal budget;

2) budgetary allocations to the budgets of the constituent entities of the Russian Federation;

3) funds from organizations that have received permission to organize a clinical trial of a biomedical cell product;

4) other sources not prohibited by the legislation of the Russian Federation.

4. Clinical trials of biomedical cell products are carried out on the basis of a permit to conduct a clinical trial of a biomedical cell product, issued by the authorized federal executive body in the manner established by Articles 16 and 17 of this Federal Law, and are aimed at:

1) establishing the safety and (or) tolerability of biomedical cell products, including identifying side effects during their use;

2) establishing the safety and effectiveness of biomedical cell products, including the selection of optimal dosages of the biomedical cell product and courses of treatment, for patients with certain diseases;

3) identification of features of the interaction of biomedical cell products with drugs, medical devices, food products, and other biomedical cell products;

4) study the possibility of expanding the indications for the use of registered biomedical cell products.

5. The authorized federal executive body maintains, in accordance with the procedure established by it, a register of issued permits to conduct clinical trials of biomedical cell products.

6. If a clinical trial of a biomedical cell product is carried out for state registration of this product, the state fee for conducting an examination of the quality of the biomedical cell product, examination of documents for obtaining permission to conduct a clinical trial of a biomedical cell product and ethical examination is paid once when applying for state registration biomedical cell product.

7. A clinical trial of a biomedical cell product is carried out in one or more medical organizations accredited by an authorized federal executive body in the manner established by the Government of the Russian Federation, in accordance with an agreement on conducting a clinical trial of a biomedical cell product, concluded between an organization that has received permission from an authorized federal body executive power to conduct such a study, and the specified medical organization.

8. An agreement to conduct a clinical trial of a biomedical cell product must contain:

1) names of the parties to the agreement;

2) conditions and timing of the clinical trial;

3) determination of the total cost of the clinical research program, indicating the amount intended for payments to researchers and co-investigators appointed in accordance with Part 1 of Article 29 of this Federal Law;

4) determining the form and procedure for presenting the results of a clinical trial.

9. The list of medical organizations that have the right to conduct clinical trials of biomedical cell products and the register of issued permits to conduct clinical trials of biomedical cell products are posted by the authorized federal executive body in the manner established by it on its official website on the Internet.

10. The production of a biomedical cell product for clinical research is carried out using the technology described in the registration dossier for the biomedical cell product.

11. Clinical studies of biomedical cell products are conducted in accordance with the rules of proper clinical practice biomedical cell products approved by the authorized federal executive body.

12. In the Russian Federation, in accordance with international treaties of the Russian Federation, and in the absence of an international treaty of the Russian Federation, on the basis of the principle of reciprocity, the results of clinical studies of biomedical cell products conducted outside the Russian Federation are recognized.

Article 29. Conducting a clinical trial of a biomedical cell product

1. The head of the medical organization in which a clinical trial of a biomedical cell product is being conducted appoints a researcher responsible for conducting such a study, who has a medical specialty corresponding to the profile of the disease or condition for which the biomedical cell product for which the clinical trial is being conducted is intended, with with at least five years of experience in clinical research programs (hereinafter referred to as the investigator) and, at his suggestion, appoints co-investigators from among the doctors of this medical organization (hereinafter referred to as co-investigators).

2. The researcher selects patients who medical indications may be recruited to participate in a clinical trial of a biomedical cell product.

3. The investigator and co-investigators must be familiar with the results of the preclinical study of the biomedical cell product contained in the specification for the biomedical cell product and the investigator’s brochure, the clinical trial protocol for the biomedical cell product developed by the organization organizing clinical trials of biomedical cell products, or another legal entity involved in organizing a clinical trial of a biomedical cell product, and other materials of such research.

4. The head of the medical organization in which a clinical trial of a biomedical cellular product is being conducted, within a period not exceeding three working days from the date of the start of the clinical trial of the biomedical cellular product, reports the start of the clinical trial of the biomedical cellular product to the authorized federal executive body that issued the permission to conduct a clinical trial in the form established by it.

5. Organizations organizing a clinical trial of a biomedical cell product, if it is necessary to make changes to the protocol of a clinical trial of a biomedical cell product, report this to the authorized federal executive body that issued permission to conduct a clinical trial, in the form established by it.

6. Within a period not exceeding thirty working days from the date of receipt of the message specified in Part 5 of this article, the authorized federal executive body considers this message in the manner established by it and makes a decision to amend the clinical trial protocol of a biomedical cell product or to refuse making such changes, indicating the reasons for the refusal. The grounds for making a decision to refuse to make changes to the protocol for a clinical trial of a biomedical cell product are the provision of information provided for in Part 5 of this article incompletely and (or) the presence of a risk of harm to the health of the patient participating in the clinical trial due to changes in the conditions of its conduct. .

7. A clinical trial of a biomedical cell product may be suspended or terminated if a danger to the life or health of patients is discovered during its implementation. In the event of a danger to the life or health of a patient participating in a clinical trial of a biomedical cell product, the researcher and (or) co-investigators are obliged to inform the head of the medical organization in which the clinical trial of the biomedical cell product is being conducted and (or) the organization that has received permission to conducting a clinical trial of a biomedical cell product. The decision to suspend a clinical trial of a biomedical cell product is made by the head of the medical organization in which the clinical trial of the biomedical cell product is being conducted. The decision to terminate such a study is made by the authorized federal executive body based on a written message from the head of the medical organization in which the clinical trial of the biomedical cell product is being conducted, or the organization that has received permission to conduct the clinical trial of the biomedical cell product.

8. Within a period not exceeding five working days from the date of completion, suspension or termination of a clinical trial of a biomedical cellular product, a notification about this is sent by medical organizations in which a clinical trial of a biomedical cellular product is being conducted to the authorized federal executive body in the form established by it.

9. The authorized federal executive body publishes on its official website on the Internet a message about the completion, suspension or termination of a clinical trial of a biomedical cell product within a period not exceeding five working days from the date of its receipt, in the manner established by it.

10. The authorized federal executive body, in accordance with the procedure approved by it, maintains the State Register of Researchers, which is subject to posting on the official website of the authorized federal executive body on the Internet and contains data about the researcher (last name, first name, patronymic, place of work, position held, specialty, length of service in clinical research programs, list of clinical studies (including biomedical cell products) in which he took part as an investigator or co-investigator, and periods of his participation).

11. A report on the results of a clinical trial of a biomedical cell product is drawn up by the organization organizing the clinical trial of a biomedical cell product and submitted to the authorized federal executive body that issued permission to conduct this study within a period not exceeding three months from the date of its completion, suspension or termination, in the manner established by the authorized federal executive body.

12. The procedure for exporting from the Russian Federation biological material obtained during a clinical trial of a biomedical cell product for its study for the purposes of this clinical trial is established by the Government of the Russian Federation.

Article 30. International multicenter clinical trial of a biomedical cell product, post-registration clinical trial of a biomedical cell product

1. An international multicenter clinical trial of a biomedical cell product in the Russian Federation or a post-registration clinical trial of a biomedical cell product is carried out on the basis of a permit to conduct a clinical trial of a biomedical cell product, issued by an authorized federal executive body based on the results of an examination of the quality of the biomedical cell product, examination of documents for obtaining permission to conduct an international multicenter clinical trial of a biomedical cell product or post-registration clinical trial of a biomedical cell product and ethical review.

2. To obtain permission to conduct an international multicenter clinical trial of a biomedical cell product or a post-registration clinical trial of a biomedical cell product, the organization organizing the clinical trial of a biomedical cell product (hereinafter in this article - the applicant) submits the following documents to the authorized federal executive body and intelligence:

1) an application for permission to conduct an international multicenter clinical trial of a biomedical cell product or a post-registration clinical trial of a biomedical cell product;

2) details of the document confirming payment of the state fee for issuing permission to conduct an international multicenter clinical trial of a biomedical cell product or for issuing permission to conduct a post-registration clinical trial of a biomedical cell product, or this document itself (on one’s own initiative). If this document is not submitted, the authorized federal executive body, based on the details of this document submitted by the applicant, verifies the fact of payment of the state duty using information on the payment of state duties contained in the State Information System on State and Municipal Payments;

3) a report on preclinical studies of a biomedical cell product and a report on previously conducted clinical studies of a biomedical cell product (if available);

4) a draft protocol for an international multicenter clinical trial of a biomedical cell product or a post-registration clinical trial of a biomedical cell product;

5) researcher's brochure;

6) patient information sheet;

7) information about the work experience of researchers in relevant specialties and their experience in conducting clinical studies of biomedical cell products;

8) information about medical organizations in which it is proposed to conduct a clinical trial of a biomedical cell product (full and abbreviated names, legal form, location and place of activity, telephone, fax, e-mail address, information about accreditation for the right to conduct clinical trials biomedical cell products of each medical organization);

9) the expected timing of the clinical trial of the biomedical cell product;

10) a copy of the compulsory insurance agreement concluded in accordance with the standard rules of compulsory insurance, indicating the maximum number of patients participating in the clinical trial of a biomedical cell product;

11) information on the composition of the biomedical cell product;

12) a document drawn up by the manufacturer of a biomedical cell product and containing information on the qualitative composition, quantitative composition and other characteristics of the biomedical cell product produced for clinical trials.

3. Within a period not exceeding five working days from the date of submission of the documents and information specified in Part 2 of this article, the authorized federal executive body:

1) checks the completeness and accuracy of the information contained in the documents submitted by the applicant;

2) decides to conduct an examination of the quality of a biomedical cell product, an examination of documents to obtain permission to conduct an international multicenter clinical trial of a biomedical cell product or a post-registration clinical trial of a biomedical cell product and ethical examination or to refuse to conduct these examinations;

3) notifies the applicant in writing about the decision made (if a decision is made to refuse to conduct the relevant examination, indicates the reasons for such refusal).

4. If information contained in the materials submitted by the applicant is identified as incomplete or unreliable, the authorized federal executive body sends the applicant a request to clarify the specified information. This request can be submitted to the authorized representative of the applicant in person against signature, sent by registered mail or transmitted electronically via telecommunication channels. If this request is sent by registered mail, it is considered received after six days from the date of sending the registered letter.

5. The applicant is obliged to submit a response to the request of the authorized federal executive body within a period not exceeding ninety working days from the date of receipt of this request. The period specified in Part 3 of this article is suspended from the day the authorized federal executive body sends the request specified in Part 4 of this article to the applicant until the day it receives a response to this request and is not taken into account when calculating the period for the authorized federal executive body to make a decision to conduct an examination quality of a biomedical cell product, examination of documents to obtain permission to conduct an international multicenter clinical trial of a biomedical cell product or post-registration clinical trial of a biomedical cell product.

6. The basis for refusal to conduct an examination of the quality of a biomedical cellular product, examination of documents for obtaining permission to conduct an international multicenter clinical trial of a biomedical cellular product or post-registration clinical trial of a biomedical cellular product and ethical examination is the submission of documents provided for in Part 2 of this article incompletely , failure to submit a response within the prescribed period to the request of the authorized federal executive body specified in Part 4 of this article or the absence in the submitted documents of information that should be reflected in them, as well as the absence of information confirming the payment of the state fee for issuing permission to conduct an international multicenter clinical trial research of a biomedical cell product or permission to conduct a post-registration clinical trial of a biomedical cell product.

7. Conducting an examination of the quality of a biomedical cell product, examination of documents to obtain permission to conduct an international multicenter clinical trial of a biomedical cell product or a post-registration clinical trial of a biomedical cell product and ethical examination and issuance of permission to conduct an international multicenter clinical trial of a biomedical cell product or a post-registration clinical trial of a biomedical product cell product are carried out in accordance with Articles 14 - 17 of this Federal Law.

8. Decisions to refuse to conduct an examination of the quality of a biomedical cell product, examination of documents for obtaining permission to conduct an international multicenter clinical trial of a biomedical cell product or a post-registration clinical trial of a biomedical cell product and ethical examination and to issue permission to conduct an international multicenter clinical trial of a biomedical cell product or post-registration clinical trial of a biomedical cell product may be appealed in the manner established by the legislation of the Russian Federation.

Article 31. Rights of a patient participating in a clinical trial of a biomedical cell product

1. Patient participation in a clinical trial of a biomedical cell product is voluntary and is confirmed by his signature or the signature of his legal representative on the patient information sheet.

2. The patient or his legal representative must be informed in writing:

1) about a biomedical cell product;

2) the purpose and duration of the clinical trial of the biomedical cell product;

3) guarantees of confidentiality of participation in a clinical trial of a biomedical cell product;

4) about the conditions for participation in a clinical trial of a biomedical cell product;

5) about the expected effectiveness of the biomedical cell product, as well as the degree of risk that the patient may be exposed to in connection with participation in a clinical trial of the biomedical cell product;

6) about the patient’s actions in the event of unforeseen effects of the biomedical cellular product on his health;

7) on the conditions of compulsory life and health insurance of the patient.

3. The patient or his legal representative has the right to refuse to participate in a clinical trial of a biomedical cell product at any stage of such a trial.

4. Conducting a clinical trial of a biomedical cell product with the participation of children as patients is permitted only with the written voluntary consent of their parents. Children may be considered as patients of such a study if it is necessary for the treatment of a disease in of this child. In these cases, such a study can be carried out on the basis of a decision of a council of doctors created in accordance with Federal Law of November 21, 2011 N 323-FZ “On the fundamentals of protecting the health of citizens in the Russian Federation”, on the possibility of a child’s participation in a clinical trial of a biomedical cell product and provided that such a study was preceded by a study of this biomedical cellular product on adult citizens, with the exception of cases of conducting a clinical study of a biomedical cellular product intended for the treatment of diseases exclusively in children.

5. It is allowed to conduct a clinical trial of a biomedical cell product with the participation as a patient of a person recognized as legally incompetent or partially capable, with the written voluntary consent of his legal representative. The decision on the possibility of participation of the specified person in such a clinical trial is made by a council of doctors, which includes specialists in the profile of the patient’s disease.

6. It is prohibited to conduct a clinical trial of a biomedical cell product with the participation as patients of:

1) orphans and children left without parental care;

2) women during pregnancy, childbirth, women during breastfeeding, except for cases where the appropriate treatment method is intended for these patients and provided that all necessary measures are taken to eliminate the risk of harm to the woman during pregnancy, childbirth, and women during breastfeeding feeding, fetus or child;

3) military personnel, with the exception of cases of conducting a clinical trial of a biomedical cell product specifically designed for use in military operations, emergency situations, prevention and treatment of diseases and injuries resulting from exposure to adverse chemical, biological, and radiation factors. A clinical trial of such a biomedical cell product may be conducted with the participation of military personnel as patients, with the exception of military personnel undergoing conscription military service, in compliance with the requirements established by this Federal Law in relation to civilians;

4) law enforcement officers;

5) persons serving sentences in places of deprivation of liberty, as well as persons in custody in pre-trial detention centers.

Article 32. Mandatory life and health insurance of a patient participating in a clinical trial of a biomedical cell product

1. An organization that has received permission to organize a clinical trial of a biomedical cell product is obliged, as an insurer, to insure the risk of harm to the life and health of the patient as a result of conducting a clinical trial of a biomedical cell product at its own expense by concluding a compulsory insurance agreement.

2. The object of compulsory insurance is the patient’s property interest associated with harm to the patient’s life and health as a result of a clinical trial of a biomedical cell product.

3. An insured event under a compulsory insurance contract is the death of a patient or a deterioration in his health, including one entailing the establishment of disability, if there is a cause-and-effect relationship between the occurrence of this event and the patient’s participation in a clinical trial of a biomedical cell product.

4. Claims for compensation for harm caused to the life or health of a patient are submitted within the limitation periods established by civil law.

5. The amount of insurance under the compulsory insurance contract is two million rubles.

6. The amount of insurance payment under the compulsory insurance contract is:

1) in the event of the death of a patient, two million rubles for each patient participating in a clinical trial of a biomedical cell product;

2) if the patient’s health deteriorates:

a) resulting in the establishment of group I disability, one million five hundred thousand rubles for each patient participating in a clinical trial of a biomedical cell product;

b) resulting in the establishment of group II disability, one million rubles for each patient participating in a clinical trial of a biomedical cell product;

c) resulting in the establishment of disability Group III, five hundred thousand rubles for each patient participating in a clinical trial of a biomedical cell product;

d) which did not entail the establishment of disability or resulted in an increase in the degree of limitation of the disabled person’s life activity without changing the disability group, no more than three hundred thousand rubles for each patient who participated in a clinical trial of a biomedical cell product, based on standards reflecting the nature and degree of harm to health, as well as actual expenses incurred by the patient related to harm to health, for medical care, purchase of medicines and medical devices.

7. The compulsory insurance contract is concluded for a period covering the period of conducting a clinical trial of a biomedical cell product, and for at least one year after the completion of a clinical trial of a biomedical cell product.

8. Terms of the compulsory insurance contract, including insurance rates for compulsory insurance, a list of necessary documents for making insurance payments, the procedure for the policyholder to establish an individual patient identification code, the procedure for the policyholder to inform the insurer about patients involved in a clinical trial of a biomedical cell product, the procedure for paying the insurance premium , the procedure for the implementation of the rights and obligations of the parties defined by this Federal Law and other federal laws, standards reflecting the nature and degree of damage to health under a compulsory insurance contract are established by the standard rules of compulsory insurance.

9. In case of harm to the life of a patient who participated in a clinical trial of a biomedical cell product, the beneficiaries under the compulsory insurance contract are citizens who have the right to compensation for harm in the event of the death of the breadwinner in accordance with civil law; in the absence of such citizens - parents, spouse ), children of a deceased patient who participated in a clinical trial of a biomedical cellular product, in the event of the death of a patient who participated in a clinical trial of a biomedical cellular product and did not have independent income - citizens on whom he was dependent, in relation to reimbursement of funeral expenses for the patient who participated in a clinical trial of a biomedical cell product, the person who incurred such expenses.

10. Insurance payment to compensate for harm caused to the life of a patient who participated in a clinical trial of a biomedical cell product is distributed among beneficiaries in proportion to their number in equal shares.

11. Upon the occurrence of an insured event, a patient who participated in a clinical trial of a biomedical cell product, the beneficiary under a compulsory insurance contract, has the right to submit directly to the insurer a claim for compensation for damage caused. Insurance payment is made by the insurer within thirty days from the date of submission of the necessary documents. A patient participating in a clinical trial of a biomedical cell product, or a beneficiary under a compulsory insurance contract, is obliged to inform the insurer in order to make an insurance payment the individual identification code of the patient, established by the policyholder in accordance with the standard rules of compulsory insurance.

12. Until the full determination of the amount of damage subject to compensation, the insurer, at the request of a patient participating in a clinical trial of a biomedical cell product, or at the request of a beneficiary, has the right to make a portion of the insurance payment corresponding to the actually determined portion of the damage caused.

13. Insurance payment in accordance with the compulsory insurance contract is carried out regardless of payments due under other types of insurance.

14. Participation of a patient in a clinical trial of a biomedical cell product is not permitted in the absence of a compulsory insurance agreement.

15. Control over the fulfillment by an organization that has received permission to conduct a clinical trial of a biomedical cellular product of the obligation established by this article to insure the life and health of the patient participating in the clinical trial of a biomedical cellular product is carried out by the authorized federal executive body that issued the permit to conduct a clinical trial of a biomedical product. cellular product.

Article 33. Obtaining biological material

1. Obtaining biological material from a donor of biological material for the production of biomedical cell products, including for the purpose of conducting preclinical studies and (or) clinical studies, and a medical examination of the donor of biological material in order to identify contraindications for obtaining biological material from him are carried out in organizations having a license for medical activities, on the basis of an agreement between such an organization and the manufacturer of biomedical cell products at the expense of the specified manufacturer.

2. The rules for obtaining biological material for the production of biomedical cell products and transferring it to the manufacturer of biomedical cell products are established by the authorized federal executive body.

3. Obtaining biological material for the production of biomedical cell products during lifetime donation is permitted if the donor has the following expressed in writing and included in the medical documentation:

1) informed voluntary consent of an adult capable person or a minor person declared fully capable in accordance with the procedure established by law, who has undergone a medical examination, to provide his biological material free of charge for the production of a biomedical cell product, including for the purpose of conducting preclinical studies and (or) clinical studies ;

2) informed voluntary consent of one of the parents or other legal representative of a minor person (except for the minor person specified in paragraph 1 of this part), as well as a person recognized in the manner prescribed by law as incompetent or partially capable, for the free provision of biological material of this person for production of a biomedical cell product, including for the purpose of conducting preclinical studies and (or) clinical studies. Obtaining biological material from the persons specified in this paragraph is permitted only in cases where the biomedical cell product is intended for use exclusively by these persons or their relatives - biological parents, natural children, siblings.

4. The person specified in paragraph 1 of part 3 of this article may, in writing, certified by the head of a medical organization or notarized, express his will of consent or disagreement to the posthumous provision of his biological material for the production of a biomedical cellular product.

5. In the absence of the expressed will of the person specified in paragraph 1 of part 3 of this article in relation to posthumous donation, after his death, obtaining biological material for the production of a biomedical cell product after his death is permitted with the written consent of the spouse of the deceased, and with his ( her) absence - one of the relatives (children, parents, adopted children, adoptive parents, siblings, grandchildren, grandparents), certified by the head of the medical organization or his authorized person or by a notary.

6. Information about the existence of the will of the person specified in part 4 of this article, other persons in the case provided for by part 5 of this article, is entered into the donor’s medical documentation.

7. Obtaining biological material during posthumous donation is not permitted:

1) if during his lifetime the person specified in paragraph 1 of part 3 of this article expressed his will orally in the presence of witnesses about his disagreement with the posthumous provision of biological material for the production of a biomedical cell product and data about this was entered into the medical documentation of this person in the manner, established by the authorized federal executive body;

2) from a deceased minor, with the exception of those specified in paragraph 1 of part 3 of this article, or from a person recognized as legally incompetent;

3) in the absence of both the will expressed during life by the person specified in paragraph 1 of part 3 of this article on consent to the posthumous provision of biological material for the production of a biomedical cell product, and the consent of his spouse, and in his (her) absence - one of the relatives specified in part 5 of this article.

8. Form of informed voluntary consent of the donor of biological material or one of the parents or other legal representative of the person specified in paragraph 2 of part 3 of this article for the free provision of biological material for the production of a biomedical cell product, including for the purpose of conducting preclinical studies and (or ) clinical trials, a form of written consent of the spouse or one of the relatives specified in part 5 of this article, of a deceased person for the posthumous provision of biological material for the production of a biomedical cell product, including for the purpose of conducting preclinical studies and (or) clinical studies , are approved by the authorized federal executive body.

Article 34. Rights and obligations of the donor of biological material, his parents and other legal representatives

1. The donor of biological material during lifetime donation (one of his parents or other legal representative) has the right:

1) to protect the rights and health of the donor;

2) to familiarize yourself with the results medical examination donor;

3) to receive in an accessible form information about the biomedical cellular product for the production of which biological material is provided, about the procedure for obtaining and using biological material, about possible consequences removal of biological material for the health of the donor;

4) to receive medical care within the framework of the state guarantee program for the provision of free medical care to citizens in the event that the donor experiences reactions and complications associated with donation;

5) to refuse at any time to provide biological material.

2. The donor of biological material (one of his parents or other legal representative) during lifetime donation is obliged to inform:

1) information about diseases known to him, suffered by the donor and (or) existing in the donor;

2) information about the donor’s drug use, psychotropic substances, medications;

3) other information relevant to ensuring the safe donation of biological material, the list of which is approved by the authorized federal executive body.

3. The donor of biological material during lifetime donation is required to undergo a medical examination. This medical examination is free for the donor. The procedure for medical examination of a donor and the list of contraindications (absolute and relative) for obtaining biological material are approved by the authorized federal executive body.

4. A donor of biological material (one of his parents or another legal representative) during lifetime donation, who deliberately concealed or distorted information known to him about the health status of the donor during lifetime donation of biological material, as a result of which harm was caused to the life, health of the patient, medical employees and other persons bear responsibility established by the legislation of the Russian Federation.

Article 35. Production and sale of biomedical cell products

1. The production of a biomedical cell product is carried out in compliance with the requirements of the regulations for its production, which is approved by the manufacturer of the biomedical cell product and includes:

1) a list of cell lines, drugs, medical devices and excipients used, indicating the quantity of each of them;

2) data on the equipment used, a description of the technological process and control methods at all stages of the production of a biomedical cell product.

2. The rules for the production of biomedical cell products are established by the rules of good practice for working with biomedical cell products, approved by the authorized federal executive body.

3. The production of biomedical cell products not registered in the Russian Federation, with the exception of cases of production of biomedical cell products for the purposes of preclinical studies of biomedical cell products and clinical studies of biomedical cell products, is not allowed.

4. A registered biomedical cell product of a certain type (autologous, allogeneic, combination) can be produced using cell lines prepared from biological material obtained from various donors. If the requirements established for state registration of a biomedical cell product are met, repeated state registration of such a biomedical cell product is not required.

1) falsified biomedical cell products;

2) biomedical cell products in violation of the rules of good practice for working with biomedical cell products.

6. Confirmation of the compliance of the manufactured biomedical cell product with the requirements established during its state registration and the compliance of its production process with the requirements of good practice for working with biomedical cell products is carried out by an authorized person of the manufacturer of the biomedical cell product, with the exception of biomedical cell products produced for preclinical studies and clinical research of biomedical cell products. Requirements for the level of education and qualifications, the procedure for certification of an authorized person of the manufacturer of a biomedical cell product and his powers to ensure the quality of a biomedical cell product put into circulation are established by the authorized federal executive body.

7. Manufacturers of biomedical cell products may sell biomedical cell products:

1) other manufacturers of biomedical cell products for the production of biomedical cell products;

2) scientific organizations, educational organizations for conducting scientific research;

3) organizations carrying out medical activities.

8. Rules for the sale of biomedical cell products are established by the Government of the Russian Federation.

Article 36. Labeling of biomedical cell products

1. List of information applied to primary packaging, secondary packaging of biomedical cellular products and transport containers in which the biomedical cellular product is placed are established by the authorized federal executive body.

2. Primary packaging and secondary packaging of autologous biomedical cell products and combined biomedical cell products are marked using radio frequency identification methods to identify the belonging of such biomedical cell product to a specific patient in the manner established by the authorized federal executive body.

3. The primary packaging and secondary packaging of biomedical cell products intended for preclinical research or clinical trials shall be marked: “For preclinical research” or “For clinical research.”

Article 37. Transportation and storage of biological material, cells for the preparation of cell lines, cell lines intended for the production of biomedical cell products, biomedical cell products

1. Biological material, cells for the preparation of cell lines, cell lines intended for the production of biomedical cell products, biomedical cell products must be transported in compliance with the transportation rules established by the authorized federal executive body.

2. Biological material, cells for the preparation of cell lines, cell lines intended for the production of biomedical cell products, biomedical cell products must be stored in biobank conditions that ensure the preservation of their biological properties and prevent their infection and contamination.

3. Requirements for the organization and operation of biobanks, as well as rules for storing biological material, cells for the preparation of cell lines, cell lines intended for the production of biomedical cell products, biomedical cell products are established by the authorized federal executive body.

Article 38. Destruction of unclaimed biological material, unclaimed cells for the preparation of cell lines, unclaimed cell lines intended for the production of biomedical cell products, unclaimed biomedical cell products

1. Unclaimed biological material, unclaimed cells for the preparation of cell lines, unclaimed cell lines intended for the production of biomedical cell products, unclaimed biomedical cell products are subject to destruction in the manner established by legislation in the field of health protection.

2. Falsified biomedical cell products or substandard biomedical cell products are subject to withdrawal from circulation by decision of the federal executive body exercising control and supervision functions in the field of healthcare. Subsequent destruction of falsified biomedical cell products or substandard biomedical cell products is carried out on the basis of a decision of the owner of the biomedical cell product and (or) a decision of the federal executive body exercising control and supervision functions in the field of healthcare, or a court decision.

3. Counterfeit biomedical cell products are subject to withdrawal from circulation and destruction by court decision.

4. The procedure for the destruction of falsified biomedical cell products, substandard biomedical cell products and counterfeit biomedical cell products is established by the Government of the Russian Federation.

5. Costs associated with the destruction of falsified biomedical cell products, substandard biomedical cell products and counterfeit biomedical cell products shall be reimbursed by their owners.

6. The owner of a biomedical cellular product must submit to the federal executive body exercising control and supervision functions in the field of healthcare a document confirming the fact of destruction of the biomedical cellular product, or a duly certified copy thereof.

7. The federal executive body exercising the functions of control and supervision in the field of healthcare, which has made a decision to destroy a biomedical cell product, monitors the implementation of this decision.

Article 39. Features of medical care using biomedical cell products

1. Medical care using biomedical cell products can be provided medical workers who have completed additional training professional program(advanced training program) on the use of biomedical cell products. Approximate additional professional programs (advanced training programs) on the use of biomedical cell products are approved by the authorized federal executive body.

2. Self-administration of biomedical cell products by the patient is not permitted.

3. Biomedical cell products, which include cell lines obtained from biological material from a donor of biological material that has contraindications included in the list of contraindications (absolute and relative) for obtaining biological material for the production of biomedical cell products, can be used to treat only the same donor of this biological material (autologous use).

Article 40. Biomedical Cell Products Information

1. Information about biomedical cell products should be contained only in specialized publications, including monographs, reference books, scientific articles, reports at congresses, conferences, symposiums, scientific councils, on specialized websites on the Internet, as well as in instructions for the use of biomedical cell products and other information materials intended for medical professionals.

2. It is permitted to use any material media that allows storing, transmitting and using information about biomedical cell products without distortion.

Article 41. Safety monitoring of biomedical cell products

1. Biomedical cell products in circulation in the Russian Federation are subject to safety monitoring in order to identify possible negative consequences of their use, which is carried out by the federal executive body exercising control and supervision functions in the field of healthcare, in the manner established by it, based on reports provided for in parts 2 and 3 of this article.

2. Subjects of circulation of biomedical cell products are required to send reports about side effects, adverse reactions, serious adverse reactions, unexpected adverse reactions when using biomedical cell products, individual intolerance, lack of effectiveness of biomedical cell products, and the peculiarities of their interaction with drugs and medical devices , food products, other biomedical cell products, as well as other facts and circumstances that pose a threat to human life or health when using biomedical cell products and identified at all stages of circulation of biomedical cell products in the Russian Federation.

3. Organizations providing medical care to pregnant women, women in labor, postpartum women and newborns are required to send reports on all cases of birth of children with congenital anomalies or developmental defects if biomedical cell products were previously used in relation to one of the parents of such children during medical intervention.

4. Owners of registration certificates of biomedical cell products, legal entities in whose name permits have been issued to conduct clinical trials of biomedical cell products, or other legal entities authorized by them within the framework of ensuring the safety of biomedical cell products in the manner established by the federal executive body exercising the functions of control and supervision in the field of healthcare are required to receive, record, process, analyze and store messages received from subjects of circulation of biomedical cell products and government authorities about side effects, adverse reactions, serious adverse reactions, unexpected adverse reactions when using biomedical cell products, about the peculiarities of their interaction with drugs, medical devices, food products, other biomedical cell products, about individual intolerance, as well as about other facts and circumstances that pose a threat to human life or health or affect a change in the ratio of expected benefit to possible risk applications of biomedical cell products.

5. When identifying the information provided for in Part 4 of this article, the owners of registration certificates of biomedical cell products, legal entities in whose name permits to conduct clinical trials of biomedical cell products have been issued, or other legal entities authorized by them are obliged to take measures aimed at eliminating the negative consequences the use of such biomedical cell products, the prevention of harm to human life or health, the protection of patients from the use of such biomedical cell products, for the additional collection of data on the effectiveness and safety of such biomedical cell products.

Article 42. Suspension of the use of a biomedical cell product

1. The federal executive body exercising the functions of control and supervision in the field of healthcare shall, in the manner established by the authorized federal executive body, make a decision to suspend the use of a biomedical cell product:

1) upon receipt of information about side effects not specified in the instructions for use of a biomedical cell product, serious adverse reactions and unexpected adverse reactions, about the peculiarities of the interaction of a biomedical cell product with drugs, medical devices, food products, and other biomedical cell products that may pose a threat to human life or health, as well as a discrepancy between the data on the effectiveness of the biomedical cell product and the safety of the biomedical cell product with the data contained in the instructions for its use;

2) in case of non-fulfillment or improper fulfillment by the owners of registration certificates of biomedical cell products, legal entities in whose name permissions to conduct clinical trials of biomedical cell products have been issued, or other legal entities authorized by them, of the obligations established by parts 4 and 5 of Article 41 of this Federal Law;

3) in the event of a conclusion about the unreliability of the results of a clinical trial of a biomedical cell product, which is based on the results of an inspection of a medical organization that conducted the specified clinical trial in violation of the rules of good practice for working with biomedical cell products, or in case of failure to comply with the instructions based on the results of random quality control biomedical cell product.

2. The federal executive body exercising the functions of control and supervision in the field of healthcare, based on the results of monitoring the safety of biomedical cell products, publishes on its official website on the Internet information about the decision made to suspend the use of a biomedical cell product and (or) related to decision on the possible resumption of use of the biomedical cell product.

Article 43. Procedure for import into the Russian Federation and export from the Russian Federation of biomedical cell products

1. Import of biomedical cell products into the Russian Federation is carried out in the manner established by the Government of the Russian Federation, in accordance with international treaties and acts that constitute the law of the Eurasian economic union(hereinafter referred to as the law of the EAEU), and (or) the legislation of the Russian Federation on customs affairs.

2. Biomedical cell products imported into the Russian Federation must be included in the state register of biomedical cell products.

3. The import of biomedical cellular products into the Russian Federation is allowed, the quality of which is confirmed by a certificate from the manufacturer of the biomedical cellular product, certifying the compliance of the imported biomedical cellular products with the requirements of regulatory documentation for the biomedical cellular product.

4. Import into the Russian Federation of a specific batch of an unregistered biomedical cell product intended for its state registration (including for biomedical examination, preclinical studies and clinical trials) or for the provision of medical care to a specific patient for life-saving indications is permitted with the permission of the authorized federal executive authority upon applications of persons specified in Article 44 of this Federal Law. Consideration of such an application and a decision to issue a permit for the import of biomedical cell products or to refuse to issue the said permit are carried out on the basis of the specification for the biomedical cell product attached to the application within a period not exceeding ten working days from the date of acceptance of such an application by the authorized federal executive body . There is no fee for issuing this permit.

5. When importing biomedical cell products into the Russian Federation in Customs The following documents are submitted to the Russian Federation, along with documents the submission of which is provided for by the law of the EAEU and (or) the legislation of the Russian Federation on customs affairs:

1) certificate of the manufacturer of the biomedical cell product, certifying the compliance of the imported biomedical cell product with the requirements of regulatory documentation for the biomedical cell product;

2) specification for a biomedical cell product;

3) permission from the authorized federal executive body to import a specific batch of biomedical cell product in the cases specified in part 4 of this article.

6. The import into the Russian Federation of counterfeit biomedical cell products, substandard biomedical cell products, and counterfeit biomedical cell products is prohibited.

7. The export of biomedical cell products from the Russian Federation is carried out without applying restrictions established by the law of the EAEU and (or) the legislation of the Russian Federation on foreign trade activities, unless otherwise established by international treaties of the Russian Federation.

8. The export of biomedical cell products intended for humanitarian aid (assistance) or assistance in emergency situations from the Russian Federation is carried out in the manner established by the Government of the Russian Federation.

Article 44. Legal entities that are allowed to import biomedical cell products

Biomedical cell products can be imported into the Russian Federation by the following legal entities:

1) a manufacturer of a biomedical cell product for the purpose of its own production of a biomedical cell product;

2) an organization that has rights to the results of preclinical studies of a biomedical cell product, clinical studies of a biomedical cell product and (or) the production technology of a biomedical cell product, or a legal entity authorized by it to carry out state registration of a biomedical cell product;

3) educational organizations of higher education and (or) organizations of additional professional education participating in the organization of preclinical studies and (or) clinical studies of biomedical cell products or conducting such studies, as well as other organizations that participate in the organization of preclinical studies and (or) ) clinical trials of biomedical cell products or in which such trials are conducted;

4) medical organizations and organizations specified in paragraphs 1 - 3 of this article to provide medical care to a specific patient for life-saving reasons, subject to a permit from the authorized federal executive body, issued in the manner established by the authorized federal executive body, in the form of an electronic document signed by an enhanced qualified electronic signature.

Article 45. Interaction between the federal executive body authorized in the field of customs affairs and the authorized federal executive body

1. The authorized federal executive body makes available to the federal executive body authorized in the field of customs the state register of biomedical cell products, as well as information on issued permits for the import of a specific batch of biomedical cell products in the cases specified in Part 4 of Article 43 of this Federal Law.

2. The federal executive body authorized in the field of customs affairs shall inform the authorized federal executive body about the import of biomedical cell products into the Russian Federation and the export of biomedical cell products from the Russian Federation in the form and in the manner established by the Government of the Russian Federation.

Article 46. State control in the field of circulation of biomedical cell products

1. State control in the sphere of circulation of biomedical cell products is carried out by the federal executive body exercising control and supervision functions in the field of healthcare, and includes licensing control in the field of production of biomedical cell products, state control over activities in the field of circulation of biomedical cell products, selective quality control of biomedical cell products.

2. Licensing control in the production of biomedical cell products is carried out in accordance with the Federal Law of May 4, 2011 N 99-FZ “On Licensing” individual species activities".

3. State control over activities in the field of circulation of biomedical cell products is carried out in accordance with the Federal Law of December 26, 2008 N 294-FZ “On the protection of the rights of legal entities and individual entrepreneurs in the exercise of state control (supervision) and municipal control”, taking into account the specifics provided for by this article, and in the manner established by the Government of the Russian Federation.

4. State control over activities in the field of circulation of biomedical cell products includes:

1) organizing and conducting inspections of compliance by subjects of circulation of biomedical cell products established by this Federal Law and other regulatory legal acts of the Russian Federation adopted in accordance with it, requirements for preclinical studies, clinical trials, production, sales, storage, transportation, import into the Russian Federation, export from the Russian Federation, use, destruction of biomedical cell products;

2) organizing and conducting inspections of the compliance of biomedical cell products in circulation with the quality indicators established by the regulatory documentation for the biomedical cell product;

3) application, in the manner established by the legislation of the Russian Federation, of measures to suppress identified violations of the requirements of this Federal Law and (or) to eliminate the consequences of such violations, including making a decision to suspend the circulation of biomedical cell products and issuing orders to eliminate identified violations, and also bringing to justice those who committed such violations.

5. Preliminary agreement with the prosecutor's office on the timing of an unscheduled inspection of subjects of circulation of biomedical cell products, as well as preliminary notification of legal entities and individual entrepreneurs about the start of such an inspection is not required. The prosecutor's office is informed about the conduct of an unscheduled inspection of subjects of circulation of biomedical cell products by sending the relevant documents within three working days from the date of completion of such an inspection.

6. Selective quality control of biomedical cell products is carried out in the manner established by the authorized federal executive body, and includes:

1) processing of information mandatory provided by subjects of circulation of biomedical cell products about series and batches of biomedical cell products entering circulation in the Russian Federation;

2) sampling of biomedical cell products from subjects of circulation of biomedical cell products for the purpose of testing for their compliance with the requirements of regulatory documentation for a biomedical cell product;

3) making a decision on further circulation of the corresponding biomedical cell product based on the results of the tests;

4) adoption by the federal executive body exercising the functions of control and supervision in the field of healthcare of a decision to transfer a biomedical cell product to serial selective quality control in the event of repeated detection of non-compliance of the quality of a biomedical cell product with the requirements of regulatory documentation for a biomedical cell product and (if necessary) on conducting an inspection of the subject of circulation of biomedical cell products. The costs associated with conducting serial selective quality control of a biomedical cell product are paid by the manufacturer of the biomedical cell product or the holder of the registration certificate of the biomedical cell product.

7. Officials of the federal executive body exercising control and supervision functions in the field of healthcare, in the manner established by the legislation of the Russian Federation:

1) on the basis of motivated written requests, receive from subjects of circulation of biomedical cell products the information necessary to make decisions on issues within the competence of the state control body;

2) upon presentation of an official ID and a copy of the order (instruction) on the appointment of an inspection, freely visit the territories, buildings, premises and structures used by the subjects of circulation of biomedical cell products for the purpose of carrying out control measures;

3) carry out sampling of biomedical cell products intended for sale and sold by subjects of circulation of biomedical cell products, to check their quality, conduct research, and test in accordance with the rules for sampling established by the authorized federal executive body;

4) issue orders to subjects of circulation of biomedical cell products to cease violations of the requirements of this Federal Law and to eliminate identified violations of these requirements.

Article 47. Liability for violation of the legislation of the Russian Federation on the circulation of biomedical cell products

Violation of the legislation of the Russian Federation on the circulation of biomedical cell products entails liability in accordance with the legislation of the Russian Federation.

Article 48. Compensation for harm caused to the life and health of citizens due to the use of biomedical cell products

1. The manufacturer of a biomedical cell product is obliged to compensate for harm caused to the life and health of citizens as a result of the use of a biomedical cell product if the presence of one of the following circumstances is proven:

1) the biomedical cell product was used for its intended purpose in accordance with the instructions for use of the biomedical cell product and the cause of harm to the life and health of citizens was the use of a substandard biomedical cell product;

2) the cause of harm to the life and health of citizens was inaccurate information contained in the instructions for use of the biomedical cell product.

2. An organization that uses a biomedical cell product is obliged to compensate for harm caused to the life and health of citizens as a result of the use of a biomedical cell product, if it is proven that the cause of harm to life and health of citizens was the use of a biomedical cell product in violation of the instructions for its use.

3. Compensation for harm caused to the life and health of citizens as a result of the use of a biomedical cellular product is carried out in accordance with the legislation of the Russian Federation.

Article 49. The procedure for the entry into force of this Federal Law

1. This Federal Law comes into force on January 1, 2017, with the exception of provisions for which this article establishes a different date for their entry into force.

2. Part 2 and paragraph 2 of part 5 of Article 35 of this Federal Law come into force on January 1, 2018.

President of Russian Federation

V. Putin

Moscow Kremlin

Law regulating the use of cell technologies in Russia: the beginning of a new industry, simplifying interaction between the medical and business communities, or complicating joint work? Anton Buzdin, a researcher at the Institute of Bioorganic Chemistry named after. Academicians M.M. Shemyakin and Yu.A. Ovchinnikova RAS, General Director of the company PONKTs (resident of the biomedical cluster of the Skolkovo Foundation). the site offers excerpts from this publication

The law (Federal Law No. 180 “On biomedical cell products”) will directly affect the medical industry, for example, aesthetic medicine. In order to rejuvenate the face and skin, SPRS therapy (Service for Personal Regeneration of Skin) was created in Russia. This is a personalized set of procedures for natural recovery skin using the patient's own cells - fibroblasts. The technology consists of isolating and growing fibroblasts (cells that produce collagen, elastin and other important components of the skin) from a small fragment of skin obtained from the patient’s postauricular area, where the cells are maximally protected from ultraviolet radiation and other unfavorable environmental factors. A sufficient quantity of fibroblasts for therapy is delivered to clinics, where certified cosmetologists use a special technique to inject them into the patient’s skin. Part of the resulting fibroblasts from the patient’s skin is placed in a cryobank, where they can be stored in liquid nitrogen in individual cells for an unlimited time and used throughout the patient’s life. Since fibroblasts are obtained from the skin of the patient undergoing therapy, many of the risks associated with the use of cellular technologies are eliminated.

Anton Buzdin (second from right) during a business mission of the biomedical cluster of the Skolkovo Foundation to Israel. Photo: website

Vadim Zorin, the developer of SPRS therapy, is the only one in Russia who has gone through all stages of developing a cell drug from the first (preclinical trials) to the final (post-marketing clinical trials) stage and received official permission from Roszdravnadzor to use the technology. According to him, the successful experience of using the technology for thousands of patients allows us to confidently speak about its safety and effectiveness.

However, not all technologies can be talked about with such confidence.

What are biomedical cell products

The document includes products containing grown living human cells. They are used in various research and medicine. It is important that the law does not cover technologies related to reproduction (for example, artificial insemination) and transplantation (for example, transplantation of bone marrow, skin, liver, kidneys and other organs and tissues). The use of cellular technologies for purely scientific or educational purposes is also not subject to the law.

We are talking about technologies that make it possible to isolate one’s own or foreign cells and use them to treat a patient. Cellular products can be used in regenerative medicine - to accelerate wound healing and tissue restoration after surgery, as well as in aesthetic medicine, for example, to rejuvenate the skin or prevent scarring. Head of the Center for Biomedical Technologies of the Central clinical hospital The Administration of the President of the Russian Federation, Ilya Eremin, mentioned in a conversation that the use of cellular products in medicine has long been the present, and not the future, including in Russian clinics. Some Russian medical organizations have accumulated quite a lot of experience in the use of cellular products. With the adoption of the law, real rules emerged that determine the process of legitimizing the development of regenerative medicine.

For example, all manipulations with cell cultures intended for administration to a patient will be regulated. Previously, such serious actions as genetic modification of cells, changes in conditions and duration of their cultivation were practically uncontrolled. This resulted in an increased risk of such side effects, such as oncological transformation of cells and their uncontrolled growth. Well, the therapeutic effect of the entire procedure itself was also called into question, since it is the thoroughness of compliance with the regulations that determines the success of the use of cellular technologies.

The essence of the document

First of all, the law will “open up” the biomedical field for government regulation. In order to determine the object of regulation of the law, concepts such as “cell line”, “donor of biological material”, “cell differentiation” and many others are introduced for the first time. The law prohibits the use of biomaterial obtained from human embryos or fetuses for the production of biomedical cell products. This is forcing researchers and businesses to focus on developing products based on postnatal cells, that is, taken after birth. In many ways, this allows us to minimize the risk of malignant transformation of cells (which has been noted more than once before for embryonic stem cells), as well as reduce ethical and criminal risks.

The law states that donation of biological material is based on the principles of voluntariness and gratuitousness. The purchase and sale of biological material and such odious approaches as the artificial creation of a human embryo, interruption or disruption of the development of a human embryo or fetus for the purpose of producing biomedical cell products are prohibited. The voluntariness of donation is documented either by the donor himself, if we are talking about lifetime donation, or, if we are talking about posthumous donation, by his closest relatives. In the latter case, relatives confirm that during his lifetime he did not refuse a potential donation of this kind.

It is established that medical care using cellular products can only be provided by medical workers who have completed training in a specialized additional professional program. Self-administration of biomedical cell products by a patient is not permitted by law.

A requirement is also being introduced for mandatory registration of cell products “for the first time to be put into circulation in the Russian Federation” for use in medicine. The registration certificate is issued for a period of five years and is then renewed. To obtain registration, the rules of ethical examination, preclinical and clinical studies, as well as the procedure for interaction with government agencies are regulated. Ultimately, the decision to register is made on the basis of an examination of the ratio of the expected benefit to the possible risk of using the product.

At the same time, the law does not have retroactive effect, and products that were previously registered in one form or another are not subject to mandatory re-registration. This norm was initially stricter, but was edited in cooperation with representatives of the business community.

To register biomedical cell products, a special state register and a special authorized federal body are being created, which causes discussion in the specialized expert community - after all, the corresponding market in Russia today is extremely small, and the creation of a new bureaucratic body seems excessive to many. Perhaps it would be more effective to transfer the corresponding powers to some existing structure.

Another very important provision of the law, which my colleagues welcome, is a set of measures to protect a patient caught in a group clinical trials cellular product. The patient must be informed in writing about the product itself and its expected effectiveness, as well as about the purpose and duration of the study, as well as the degree of risk to which he may be exposed in connection with participation in the study.

The life and health of the subject are subject to compulsory insurance at the expense of the organization testing the technology. Moreover, in the event of an insured event, payments, according to the law, must vary in the range from 500 thousand to 2 million rubles, if we are talking about the patient’s disability or his death during the research.

The impact of the law on innovation in Russia

Almost all of my colleagues agree on some positive features of the document: the important area of medical technology is finally being taken out of the “gray” area. Sergey Larin, Deputy Director of the Higher School of Molecular and Experimental Medicine, Center for Pediatric Hematology, Oncology and Immunology named after. Dima Rogacheva, creator of Russia's first gene-cell antitumor vaccines for immunogenotherapy malignant tumors, believes that the procedure for registering new products prescribed in the law will give confidence to investors investing in their development. This will strengthen the pool of domestic high-tech industries in this area and accelerate the pace of implementation of new developments. Accordingly, the prerequisites are being created for creating products that are competitive on the world market.

The law does not regulate scientific developments, therefore, to the situation with fundamental research it most likely won't have any effect. At the same time, the procedure for undergoing preclinical and clinical trials prescribed by law implies significantly larger volumes of investment in each product. This will certainly increase the cost of developing and bringing each product to market. Other scientists agree with this. Thus, the laboratories of Vadim Zorin, Ilya Eremin and Pavel Kopnin from the Cancer Center named after. Blokhin was the first to establish that the mobile part of the gum is the best source of stem cells today, capable of differentiation (transformation), including muscle tissue, which has long been an unsolved problem. The scientists' work was published in 2016 in the prestigious journal Cell Cycle. According to Eremin, this is a huge potential for introducing technology into the clinic; now, thanks to the law, all the stages necessary for introducing a new product into clinical practice have become clear.

The law is a good initiative. However, unfortunately, it does not yet have any provisions to stimulate investment in the industry, does not provide for the possibility of accelerated registration for a number of products where appropriate, does not have simplified requirements for minimally manipulated products and contains a number of apparently unnecessary restrictions on xenogeneic cells and embryonic cell lines. Overall, the law has more advantages than disadvantages for the industry. Most likely, the regulator will finalize everything else in the future.

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