Biomedical Cell Products: Regulatory Framework, Registration and Compliance in Russia and the EAEU

BRACE Law Firm©

August 31, 2026

Biomedical cell technologies represent a rapidly developing field of regenerative medicine with high expectations for treating diseases that currently lack other effective treatments. The essence of their use lies in the fact that treatment is based not on medicinal products, but on cells belonging to the patient or a donor.

Given their novelty, cell technologies constitute one of the few fields of medicine where a regulatory framework had to be created literally from scratch.

In the Russian Federation, this task was addressed through the adoption of a separate industry-specific law – Federal Law No. 180-FZ dated June 23, 2016, On Biomedical Cell Products (the "Law on BMCP", the "Federal Law No. 180-FZ"), which entered into force on January 1, 2017. The Law on BMCP is structured on a model largely borrowed from pharmaceutical legislation: it defines the concept of biomedical cell products (also the "BMCP") and regulates the stages of circulation, starting from development, preclinical and clinical trials, and ending with expertise, state registration, manufacturing, quality control, commercialization, application, storage, transportation, export from the Russian Federation, and destruction. The Law was substantially amended by Federal Law No. 466-FZ dated August 4, 2023: the main bulk of amendments has been in effect since April 1, 2024, while regarding products for which applications for state registration were submitted before that date, the new wording of Clause 1 and Clause 7 of Article 2 and Part 1 of Article 4 applies starting January 1, 2026.

In this review of legislation on BMCP prepared by BRACE Law Firm, we examine:

what biomedical cell products are;
the procedure for developing BMCP;
rules for preclinical and clinical trials, and registration of BMCP;
the correlation between Russian BMCP regulation and EAEU law;
liability for violations in the field of BMCP circulation;
what aspects businesses must consider regarding the circulation of BMCP.

What Is a Biomedical Cell Product?

Biomedical cell product means a complex consisting of a cell line (cell lines) and excipients, or of a cell line (cell lines) and excipients in combination with state-registered medicinal products for medical use and (or) pharmaceutical substances included in the state register of medicinal products, and (or) medical devices (Clause 1 of Article 2 of Federal Law No. 180-FZ).

From the given definition, the following features of BMCP can be distinguished:

1. A BMCP consists of a cell line and excipients. A product that does not contain a cell line is not a BMCP.

Cell line means a standardized population of cells of a single type with a reproducible cellular composition, obtained by withdrawing biological material from the human body (Clause 7 of Article 2 of the Law on BMCP as amended by Federal Law No. 466-FZ dated August 4, 2023). The requirement for mandatory cultivation of cells outside the human body has been excluded from the statutory definition.

Excipients mean substances of inorganic or organic origin used in the development and manufacturing of a biomedical cell product (Clause 8 of Article 2 of the Law on BMCP).

A combination of a cell line with registered medicinal products (medicinal products for medical use or pharmaceutical substances) and medical devices is also possible.

2. Preparation of a cell line outside the human body. According to Part 1 of Article 4 of Federal Law No. 180-FZ, the preparation of a cell line includes obtaining biological material, examining it, isolating cells from it, and – if necessary – culturing and modifying them outside the human body, obtaining a standardized population of cells, and assessing its compliance with the specification. The words "if necessary" mean that cultivation is not a constituent feature of BMCP: a product can be classified as a BMCP even without the cultivation stage if a standardized population of cells of a single type with a reproducible cellular composition is obtained. Accordingly, the premise that minimally manipulated cells "as a rule, are not BMCP" has no direct support in the current version of the law and requires caution during classification.

Note that Federal Law No. 466-FZ dated August 4, 2023, excluded objects of transplantation, as well as advanced therapy medicinal products, including gene therapy medicinal products subject to registration in accordance with the law of the Eurasian Economic Union and (or) state registration in accordance with Federal Law No. 61-FZ dated April 12, 2010, On the Circulation of Medicinal Products, from the concept of BMCP (Clause 1 of Article 2 of Federal Law No. 180-FZ). Part 3 of Article 3 of Federal Law No. 466-FZ establishes that registration certificates for biomedical cell products issued in accordance with the Law on BMCP remain valid until their expiration date, but no later than December 31, 2025. This provision is formulated without exemptions and applies to all BMCP registration certificates, rather than only to products reclassified as advanced therapy medicinal products or objects of transplantation. Practical consequence: starting January 1, 2026, previously issued BMCP registration certificates lost their validity, and further circulation of the respective products requires either new state registration under Federal Law No. 180-FZ, registration under EAEU rules, or transition to the individual BMCP regime.

In addition, under Part 2 of Article 1 of Federal Law No. 180-FZ, relationships arising from the development and manufacturing of medicinal products and medical devices are excluded from the scope of the law, as well as relationships whose subject matter is:

medicinal products and medical devices (in terms of their development and manufacturing);
human gametes used for the purpose of applying assisted reproductive technologies;
donation of blood and its components;
human cells and tissues whose circulation is carried out for scientific and educational purposes;
human organs and tissues whose donation is carried out for the purpose of their transplantation.

The law distinguishes three types of BMCP:

Autologous BMCP means a product that contains cell lines obtained from the biological material of a specific person and is intended for application to that same person;
Allogeneic BMCP means a product that contains cell lines obtained from the biological material of a specific person and is intended for application to other persons;
Combined BMCP means a product that contains cell lines obtained from the biological material of several persons and is intended for application to one of them.

Principles of Activity in the Field of BMCP Circulation

Article 3 of the Law on BMCP establishes a system of principles in the field of BMCP circulation:

voluntary and gratuitous donation of biological material;
compliance with medical confidentiality and other secrets protected by law;
inadmissibility of purchase and sale of biological material;
inadmissibility of creating a human embryo for the purpose of manufacturing biomedical cell products;
inadmissibility of using biological material obtained by interrupting or disrupting the development process of a human embryo or fetus for the development, manufacturing, and application of biomedical cell products;
compliance with biosafety requirements to protect the health of biological material donors, workers employed in the manufacturing of biomedical cell products, medical workers, patients, and the environment.

These principles have practical rather than declarative significance and can be used in interpreting and resolving disputed situations. Note that the principle of gratuitous donation is cornerstone. It means that a donor cannot receive remuneration for biological material. This does not preclude compensation for actual expenses (travel, meals, recovery), but precludes the commercialization of the human body. At the same time, this principle creates a practical difficulty: the selection of donors for allogeneic products is hindered.

The circulation of BMCP represents a complex life cycle consisting of several stages. Below we examine how Russian legislation regulates each stage.

Preparation of a Cell Line for BMCP Manufacturing

The preparation of a cell line includes:

obtaining biological material, examining it, and isolating cells from it;
if necessary, culturing and modifying cells outside the human body;
obtaining a standardized cell population and assessing the population's compliance with the specification for the biomedical cell product.

For the preparation of a cell line, exclusively cells of a human being or a person whose death has been ascertained in the manner established by the legislation of the Russian Federation are used (Part 2 of Article 4 of Federal Law No. 180-FZ). Obtaining and using biological material from unidentified persons who, due to health status, age, or other reasons, could not communicate data about their identity and in respect of whom death was subsequently ascertained is not permitted (Part 3 of Article 4 of Federal Law No. 180-FZ). Donation of biological material represents the most sensitive stage of BMCP preparation. The rules for obtaining biological material for BMCP manufacturing and transferring it to the manufacturer were approved by Order of the Ministry of Health of Russia No. 569n dated August 28, 2017.

Donation can be living (inter-vivos) and post-mortem.

Requirements for Living Donation of Biological Material

As a general rule, informed voluntary consent is given by a legally competent adult or a minor declared fully competent (emancipated) in the manner established by law who has undergone a medical examination (Clause 1 of Part 3 of Article 33 of the Law on BMCP). For other minors, as well as persons recognized as legally incompetent or partially competent, consent is given by one of the parents or another legal representative; meanwhile, obtaining biological material from such persons is permitted only if the BMCP is intended for application exclusively to these persons or their relatives – biological parents, native children, native brothers, and native sisters (Clause 2 of Part 3 of Article 33 of the Law on BMCP).

Conducting a medical examination of a biological material donor for the purpose of identifying contraindications in organizations holding a license for medical activity.

Presence of written informed consent. In respect of minors or persons recognized as legally incompetent or partially competent, such consent is given by the legal representative of such person. Consent is executed in writing and entered into the donor's medical documentation (Part 3 of Article 33 of the Law on BMCP); its form is approved by the authorized federal executive body (Part 8 of Article 33 of Federal Law No. 180-FZ). A donor has the right at any time to refuse to provide biological material (Clause 5 of Part 1 of Article 34 of the Law on BMCP). At the same time, the consequences of such refusal for already withdrawn biological material, the prepared cell line, and the manufactured BMCP are not regulated by law: the Law on BMCP contains neither an obligation to destroy the obtained result nor a rule on the "point of no return". This is an independent gap that in practice is closed by contractual and documentary means (scope of consent, moment of anonymization, procedure for actions upon revocation).

Requirements for Post-Mortem Donation of Biological Material

Post-mortem donation is carried out only after ascertaining the fact of death in the manner established by law.

A person has the right during their lifetime to express in writing, certified by the head of a medical organization or notarized, an expression of will regarding consent or disagreement to the post-mortem provision of their biological material (Part 4 of Article 33 of Federal Law No. 180-FZ). In the absence of a lifetime expression of will, obtaining biological material after death is permitted upon the written consent of a spouse, or in their absence – one of the relatives within the statutory circle (Part 5 of Article 33 of Federal Law No. 180-FZ). Here, the Russian legislator departed from the model of "presumed consent" operating in transplantology and applied the model of solicited consent. This is an important substantive distinction: presumed consent applies to organ transplantation, whereas it does not apply to cell products. We draw attention to the internal contradiction of Article 33: Part 5 permits post-mortem donation in the presence of consent from a spouse (relative) in the absence of a lifetime expression of will, whereas Clause 3 of Part 7 prohibits obtaining biological material in the absence of both a lifetime expression of will regarding consent and consent from a spouse (relative). A literal interpretation of Clause 3 of Part 7 effectively blocks the application of Part 5; until a law enforcement position is formed, medical organizations are advised to focus on the stricter requirement regarding the presence of both consents.

Article 34 of the Law on BMCP regulates the rights and obligations of a biological material donor, their parents, and other legal representatives. In particular, the right:

to protection of rights and health protection of the donor;
to familiarize themselves with the results of the donor's medical examination;
to receive, in an accessible form, information about the BMCP for the manufacturing of which biological material is provided, about the procedure for obtaining and using biological material, and about potential consequences of biological material withdrawal for the donor's health;
to receive medical care within the framework of the state guarantee program for free provision of medical care to citizens in the event that the donor develops reactions and complications associated with donation;
to refuse at any time to provide biological material.

A biological material donor (one of their parents or another legal representative) in living donation is obligated to report:

information on known diseases suffered by the donor and (or) existing in the donor;
information on the donor's use of narcotic drugs, psychotropic substances, or medicinal products;
other information relevant to ensuring the safe donation of biological material, the list of which is approved by the authorized federal executive body.

A donor in living donation is also obligated to undergo a medical examination, the procedure for conducting which and the list of absolute and relative contraindications are approved by the authorized federal executive body (Part 3 of Article 34 of Federal Law No. 180-FZ). A donor (their parent, another legal representative) who intentionally conceals or distorts known information about the donor's health status, as a result of which harm is caused to the life or health of a patient, medical workers, or other persons, bears liability established by the legislation of the Russian Federation (Part 4 of Article 34 of Federal Law No. 180-FZ). In addition, a BMCP containing a cell line from the biological material of a donor who has contraindications may be used only for the treatment of this donor themselves (Part 3 of Article 39 of Federal Law No. 180-FZ).

Obtaining biological material is carried out in organizations holding a license for medical activity, on the basis of an agreement between such an organization and the BMCP manufacturer and at the expense of said manufacturer (Part 1 of Article 33 of Federal Law No. 180-FZ). The medical examination of the donor is also conducted at the expense of the manufacturer; for the donor, such examination is free of charge (Part 3 of Article 34 of Federal Law No. 180-FZ). Obtaining biological material from a donor is carried out by medical specialists and (or) medical workers having secondary vocational (medical) education, in accordance with job descriptions.

Biological material, cells for preparing cell lines, cell lines, and the BMCP themselves must be stored under biobank conditions that ensure the preservation of their biological properties and prevent infection and contamination (Part 2 of Article 37 of Federal Law No. 180-FZ). Requirements for the organization and activities of biobanks and rules for storing these objects were established by Order of the Ministry of Health of Russia No. 842n dated October 20, 2017. However, detailed regulation of biobanking in Russia still remains fragmented.

In order to minimize potential disputes with the donor and their relatives, we recommend detailing the donor's consent with a view to the entire life cycle of the product, from the creation of the cell line, its storage, use for manufacturing, and commercial application.

Preclinical and Clinical Trials of BMCP

In order to confirm quality, safety, and efficacy, it is necessary to perform preclinical and clinical trials of BMCP.

Preclinical trial of BMCP means biological, microbiological, immunological, toxicological, pharmacological, physical, chemical, and other studies for the purpose of identifying the specific mechanism of action of such a product, obtaining evidence of its safety, quality, and efficacy, preceding a clinical trial of a biomedical cell product (Clause 27 of Article 2 of Federal Law No. 180-FZ).

Preclinical trials are conducted in accordance with the Good Practice Rules for Working with Biomedical Cell Products, approved by Order of the Ministry of Health of Russia No. 512n dated August 8, 2018.

To determine the scope of preclinical trials of a BMCP, the following are taken into account:

a) type of BMCP (autologous, allogeneic, and combined);

b) intended use of BMCP (prophylaxis, diagnosis, treatment of diseases or conditions, preservation of pregnancy, and medical rehabilitation);

c) presence of a medical device within the composition of BMCP;

d) presence of a genetic modification of the BMCP cell line;

e) presence of a medicinal product for medical use and (or) pharmaceutical substance within the composition of BMCP.

Preclinical trials of a BMCP must include studies of: the specific action of the BMCP on the organism, general and local toxicity, tumorigenicity, oncogenicity, and reproductive toxicity. Depending on the specifics of the product, studies may be expanded.

Based on the results of the conducted preclinical trial, a report is compiled. The report is a mandatory attachment to the documents submitted for state registration of the BMCP.

Clinical trial of BMCP (the "CT") means the study of preventive, diagnostic, therapeutic, and rehabilitative properties of a biomedical cell product in the process of its application to a human being for the purpose of obtaining evidence of its safety and efficacy, data on adverse reactions and side effects associated with its application, as well as on the effect of interaction of the investigated biomedical cell product with other biomedical cell products, medicinal products and (or) medical devices, and food products (Clause 28 of Article 2 of Federal Law No. 180-FZ).

Clinical trials are conducted in accordance with the Good Clinical Practice Rules for Biomedical Cell Products, approved by Order of the Ministry of Health of Russia No. 669n dated September 22, 2017.

Purpose of conducting clinical trials of biomedical cell products:

establishing safety and (or) tolerability of BMCP, including identifying adverse reactions during application;
establishing safety and efficacy of BMCP, including selecting the optimal quantity (volume, mass, area) of BMCP and treatment courses for patients with specific diseases;
identifying features of interaction of BMCP with medicinal products, medical devices, food products, and other BMCP;
studying the possibility of expanding indications for the application of registered BMCP.

Clinical trials are conducted on the basis of a permit from the Ministry of Health of Russia. The permit is issued based on the results of quality expertise of the biomedical cell product and expertise of documents for obtaining a permit to conduct a clinical trial. The procedure for obtaining a permit and the list of required documents are established by Order of the Ministry of Health of Russia No. 282n dated May 31, 2017.

The composition of participants in a clinical trial of BMCP includes the following persons:

1. Sponsor of the CT.

In the terminology of the law, the organization of clinical trials of BMCP may be carried out by an organization holding rights to the results of preclinical and (or) clinical trials of BMCP and (or) to its manufacturing technology, a legal entity authorized by it, as well as an educational organization of higher education, an educational organization of additional professional education, and a scientific organization (Part 1 of Article 28 of the Law on BMCP). Such an organization bears responsibility for organizing and financing the trial and, in particular:

obtains a permit from the Ministry of Health of Russia to conduct the CT;
distributes rights, duties, and responsibilities of all persons participating in the CT;
approves standard operating procedures;
selects medical organizations;
implements and maintains quality assurance and control systems;
ensures control over the quality and completeness of data obtained during the clinical trial;
ensures storage of documents relating to the CT.

For the performance of a number of functions, such as safety monitoring, it may engage another person on a contractual basis.

2. Executing organization – the medical organization conducting the CT.

The initial version of Federal Law No. 180-FZ required that clinical trials be conducted by medical organizations accredited for the right to conduct such trials. Federal Law No. 466-FZ dated August 4, 2023, eliminated the accreditation requirement: starting April 1, 2024, Part 7 of Article 28 refers to conducting the trial "in one or several medical organizations", while Articles 44 and 45 of Federal Law No. 180-FZ (which regulated accreditation) became void. Requirements for a medical organization are now determined by general rules: holding a license for medical activity, appropriate material and technical base and qualified personnel, and compliance with the Good Clinical Practice Rules for BMCP.

The list of medical organizations authorized to conduct clinical trials of BMCP is published by the Ministry of Health of Russia on its official website on the Internet.

3. Investigator.

An investigator is a physician appointed by the head of the medical organization where the trial is conducted and responsible for its conduct; must have a clinical specialty corresponding to the profile of the disease or condition for the treatment of which the BMCP is intended, and work experience in clinical trial programs of at least five years (Part 1 of Article 29 of the Law on BMCP). Upon the investigator's proposal, the head of the medical organization appoints sub-investigators from among the physicians of this organization. Information about investigators is entered into the State Register of Investigators (Part 10 of Article 29 of Federal Law No. 180-FZ).

4. Monitor means a person appointed by the sponsor to monitor the clinical trial.

The monitor performs the following actions:

verifies and controls the investigator's qualifications and the resources of the medical organization necessary for conducting the CT;
verifies compliance with requirements for the application, storage, and return procedure of BMCP;
verifies compliance by the investigator with the approved trial protocol, and the correctness, completeness, accuracy, and timeliness of documentation and data execution of the clinical trial by the investigator;
verifies the procedure for obtaining informed written voluntary consent from each patient (or their legal representative);
compiles written CT monitoring reports and submits them to the sponsor.

5. Patient – a person participating in the trial voluntarily after signing informed consent.

Article 31 of the Law on BMCP establishes restrictions regarding persons who may participate as patients in clinical trials.

Conducting a CT involving children is permitted only with the written voluntary consent of their parents. Children may be considered as patients of such a trial if its conduct is necessary for treating a disease in this child. The trial may be carried out on the basis of a decision by a medical panel regarding the child's participation and provided that such a trial was preceded by a study on adult citizens, except in cases where the BMCP is intended for treating diseases exclusively in children.

Persons recognized as legally incompetent or partially competent may participate in a CT with the written consent of a legal representative.

Conducting a clinical trial with the participation as patients of the following is prohibited:

orphans and children left without parental care;
women during pregnancy, childbirth, and breastfeeding, except in cases where the respective treatment method is intended for these patients and provided that all necessary measures are taken to exclude the risk of causing harm;
military personnel, except in cases of conducting a clinical trial specifically designed for application in conditions of military operations, emergencies, prophylaxis and treatment of diseases and injuries resulting from exposure to adverse chemical, biological, or radiation factors. Such a clinical trial is not conducted with the participation of military personnel performing military service on conscription;
law enforcement officers;
persons serving sentences in places of detention, as well as persons held in custody in pre-trial detention facilities.

Patient participation in a CT is voluntary and confirmed by their signature or the signature of their legal representative on the patient information sheet (Part 1 of Article 31 of Federal Law No. 180-FZ). The patient (their legal representative) must be informed in writing:

about the biomedical cell product;
about the purpose and duration of the CT;
about guarantees of participation confidentiality;
about conditions of participation in the CT;
about the expected efficacy of the BMCP, as well as the degree of risk to which the patient may be exposed in connection with participation in the CT;
about the patient's actions in the event of unforeseen effects of the BMCP's impact on their health status;
about the conditions of compulsory life and health insurance for the patient.

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

Another guarantee is the compulsory life and health insurance of a patient participating in a clinical trial of a biomedical cell product (Article 32 of Federal Law No. 180-FZ). The policyholder is the organization that received the permit to organize the conduct of the CT; insurance is carried out at its expense. Patient participation in a CT in the absence of a compulsory insurance contract is not permitted (Part 14 of Article 32 of Federal Law No. 180-FZ). Contract terms, insurance tariffs, and standards reflecting the nature and degree of health impairment are established by the Model Rules for Compulsory Life and Health Insurance of a Patient Participating in a Clinical Trial of a Biomedical Cell Product, approved by Decree of the Government of the RF No. 1115 dated September 18, 2017. The amount of the insurance sum under the contract is 2,000,000 rubles, and the amount of insurance payout:

in the event of the patient's death – 2,000,000 rubles;
upon deterioration of the patient's health resulting in the establishment of:
disability of Group I – 1,500,000 rubles;
disability of Group II – 1,000,000 rubles;
disability of Group III – 500,000 rubles;
not resulting in the establishment of disability or resulting in an increase in the degree of restriction of the disabled person's life activity without changing the disability group – no more than 300,000 rubles, based on standards reflecting the nature and degree of harm caused to health, as well as expenses actually incurred by the patient for medical care and the acquisition of medicinal products and medical devices.

The compulsory insurance contract is concluded for a term covering the period of conducting the CT and for at least one year after its completion.

The results of the CT are executed in a clinical trial results report, which is compiled by the organization that organized the conduct of the trial and submitted to the Ministry of Health of Russia within a period not exceeding three months from the date of completion, suspension, or termination of the trial (Part 11 of Article 29 of Federal Law No. 180-FZ). The report is included in the registration dossier. The clinical trial protocol is a different document: it defines the objectives, organizational forms, and methodology of the trial and is compiled before its commencement (Clause 16 of Article 2 of Federal Law No. 180-FZ).

Thus, given the complex nature of BMCP, preclinical and clinical trials have their specific features, which should be taken into account when conducting them.

State Registration of BMCP

Manufacturing and subsequent circulation of BMCP are permitted if they are registered by the authorized federal executive body (Part 1 of Article 8 of the Law on BMCP).

The body authorized to register BMCP is the Ministry of Health of Russia.

The applicant is an organization holding rights to the results of preclinical trials of BMCP, clinical trials of BMCP, and (or) to the manufacturing technology of BMCP, or another legal entity authorized by it (Part 1 of Article 9 of Federal Law No. 180-FZ). Thus, the criterion is not the status of the developer or manufacturer per se, but holding rights to the research results and (or) technology. The form of application and procedure for submitting documents were approved by Order of the Ministry of Health of Russia No. 32n dated January 31, 2017.

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

biomedical expertise of BMCP, including quality expertise of BMCP, expertise of documents for obtaining a permit to conduct a clinical trial, efficacy expertise, and expertise of the benefit-risk balance of application (Clause 1 of Part 3 of Article 8 of the Law on BMCP);
ethical expertise of the feasibility of conducting a clinical trial;
clinical trials of BMCP (Clause 3 of Part 3 of Article 8 of Federal Law No. 180-FZ).

Biomedical expertise is conducted in two stages: at the first stage – quality expertise and expertise of documents for obtaining a permit for a CT; at the second stage, based on the results of clinical trials – efficacy expertise and benefit-risk balance expertise (Article 12 of the Law on BMCP). Upon receiving positive conclusions of the first stage, state registration is suspended until the applicant submits an application for its resumption (Part 2 of Article 16 of the Law on BMCP), and the time spent conducting the CT is not counted when calculating the registration term.

Within 5 business days from the date of accepting the application, the Ministry of Health of Russia verifies the completeness and reliability of information contained in the submitted documents and issues an assignment to conduct biomedical expertise and ethical expertise.

The Law on BMCP does not name the expert institution by name: biomedical expertise is conducted by a federal state budgetary institution under the jurisdiction of the Ministry of Health of Russia and ensuring the fulfillment of its powers to issue permits for CTs and (or) state registration of BMCP (Article 11 of Federal Law No. 180-FZ). The respective functions are performed by the Scientific Centre for Expert Evaluation of Medicinal Products of the Ministry of Health of Russia (the "FSBI SCEEMP"); since 2024, this same institution has been conducting biomedical expertise of individual BMCP. The procedure for conducting expertise is established by Order of the Ministry of Health of Russia No. 30n dated January 31, 2017. The results of each stage of biomedical expertise are executed by a conclusion of the commission of experts of the expert institution.

Ethical expertise is conducted by the Ethics Council under the Ministry of Health of Russia. Based on the results, a conclusion is issued.

State registration of BMCP is carried out within a period not exceeding 150 business days from the date of accepting the application for state registration, or within a period not exceeding 250 business days in the event of a decision to re-conduct biomedical expertise and (or) ethical expertise (Part 4 of Article 8, Article 19 of the Law on BMCP). The time of conducting the clinical trial is not included in this period, so the actual duration of the procedure "from application to certificate" is manifold higher.

The ground for refusal of registration is an expert conclusion stating that the efficacy of the registered product is not confirmed by the obtained data or the risk of harm to human health as a result of product application exceeds the efficacy of its application (Part 2 of Article 20 of the Law on BMCP).

Upon a positive decision, the registering body:

issues a registration certificate with a validity period of 5 years; thereafter, the term is extended every five years subject to confirmation of state registration (Parts 1 and 2 of Article 21 of Federal Law No. 180-FZ). Unlike medicinal products, an indefinite registration certificate for BMCP is not provided by law – the confirmation procedure must be passed indefinitely with a five-year periodicity;
enters information into the state register of biomedical cell products, which is maintained on the official website of the Ministry of Health of Russia on the Internet.

Confirmation of state registration is carried out based on the results of benefit-risk balance expertise conducted on the basis of safety monitoring data, as well as quality expertise – in the event of making changes to regulatory documentation (Part 2 of Article 22 of the Law on BMCP). During the period of this procedure, product circulation does not cease (Part 12 of Article 22 of Federal Law No. 180-FZ).

We note that during the period the law has been in effect, the number of registered BMCP in Russia has proved to be extremely small. The reasons are a combination of high regulatory burden, narrowness of the market, lack of accumulated expert practice, and, importantly, competition with the emerging supranational regulation of ATMP. To this was added the effect of Part 3 of Article 3 of Federal Law No. 466-FZ: previously issued BMCP registration certificates ceased validity no later than December 31, 2025, so the current composition of the state register of biomedical cell products must be checked as of the date of application.

Individual Biomedical Cell Products

An exception to the general regime of BMCP circulation is constituted by individual BMCP, as well as the manufacturing of BMCP for the purposes of preclinical and clinical trials (Part 3 of Article 35 of the Law on BMCP).

Individual BMCP are understood as cell products manufactured for a specific patient directly in the medical organization where they will be applied. The legal basis of the regime is Article 32.1 of the Law on BMCP, introduced by Federal Law No. 466-FZ starting April 1, 2024.

The circulation of individual BMCP covers development, preclinical trials, expertise, manufacturing, quality control, application, storage, transportation, and destruction; clinical trials, commercialization, and export from the Russian Federation are not included in this list. The procedure of circulation is established by Decree of the Government of the RF No. 384 dated March 28, 2024, creating a separate regime.

Key principles of individual BMCP circulation include the following:

the medical organization must obtain a permit for the manufacturing and application of an individual BMCP (i.e., not a product is permitted, but the activity of a specific organization);
the permit is granted, confirmed, and canceled by the Ministry of Health of Russia; the permit is valid indefinitely subject to its confirmation every 5 years from the date of granting or last confirmation (Clause 2 of the Rules approved by Decree of the Government of the RF No. 385);
confirmation of the permit's existence serves as an entry in the register of permits; the form of the extract from the register was approved by Order of the Ministry of Health of Russia No. 245n dated May 20, 2024;
the product is manufactured directly in the medical organization where it is applied;
no fee is charged for granting, confirming, and canceling the permit, as well as for making changes to the register of permits (Clause 4 of the Rules approved by Decree of the Government of Russia No. 385); at the same time, biomedical expertise of an individual BMCP is conducted by an expert institution on a contractual basis at the applicant's expense;
upon granting and confirming the permit, the permitting body does not check the applicant's compliance with licensing requirements established by the Regulations on Licensing the Activity of Manufacturing BMCP (Clause 74 of the Rules approved by Decree of the Government of the RF No. 385) – that is, a manufacturing license for BMCP is not required for this regime.

We draw attention to the fact that both decrees (No. 384 and No. 385) entered into force on September 1, 2024, and are valid through September 1, 2030. This is a time-limited regulatory regime, which businesses should take into account when planning investments and long-term projects.

Amount of State Duty for Actions Associated with State Registration of BMCP

The amounts of state duty for performing actions associated with the implementation of state registration of BMCP are determined by Article 333.32.3 of the Tax Code of the Russian Federation. As of the date of preparing the article, state duties are:

for conducting quality expertise of BMCP, expertise of documents for obtaining a permit to conduct a clinical trial of BMCP, and ethical expertise of the feasibility of conducting such a trial upon application for state registration of BMCP – 580,000 rubles (if a CT is conducted for the purposes of state registration, this duty is paid once – Part 6 of Article 28 of the Law on BMCP);
for conducting efficacy expertise and benefit-risk balance expertise of application of BMCP upon application for its state registration – 220,000 rubles;
for conducting efficacy expertise and benefit-risk balance expertise of application of a product in respect of which international multicenter clinical trials have been conducted, some of which were conducted in the Russian Federation, upon application for state registration of a biomedical cell product – 415,000 rubles;
for issuing a permit to conduct a clinical trial of a biomedical cell product – 5,000 rubles;
for issuing a registration certificate of a biomedical cell product – 5,000 rubles;
for issuing a duplicate registration certificate of a biomedical cell product – 5,000 rubles;
for confirming state registration of a biomedical cell product – 50,000 rubles;
for making changes to documents contained in the registration dossier for a registered biomedical cell product that require conducting biomedical expertise of the biomedical cell product – 75,000 rubles;
for making changes to documents contained in the registration dossier for a registered biomedical cell product that do not require conducting biomedical expertise of the biomedical cell product – 5,000 rubles;
for issuing a permit to conduct an international multicenter clinical trial of a biomedical cell product – 100,000 rubles;
for issuing a permit to conduct a post-registration clinical trial of a biomedical cell product – 100,000 rubles.

Manufacturing and Commercialization of BMCP

Manufacturing of BMCP is carried out in compliance with the requirements of the manufacturing regulations approved by the manufacturer (Part 1 of Article 35 of the Law on BMCP) and the Good Practice Rules for Working with Biomedical Cell Products, approved by Order of the Ministry of Health of Russia No. 512n dated August 8, 2018. Note that this act is not "Good Manufacturing Practice" rules in the narrow sense. It regulates both preclinical trials (Part 3 of Article 6 of Federal Law No. 180-FZ) and BMCP manufacturing (Part 2 of Article 35 of Federal Law No. 180-FZ) in a single document.

Key elements required for BMCP manufacturing:

holding a license for the activity of manufacturing BMCP (licensing is carried out by Росздравнадзор in accordance with the Regulations approved by Decree of the Government of the RF No. 1184 dated October 3, 2018);
compliance of the BMCP with the documents of the registration dossier;
presence of a quality system that ensures compliance with rules and quality risk management;
presence of a certified qualified person of the manufacturer, who confirms that the manufactured BMCP complies with the requirements established during state registration and that the manufacturing process complies with good practice rules (the certification procedure, education and qualification requirements, and powers of such a person are established by Order of the Ministry of Health of Russia No. 694n dated September 29, 2017);
presence of qualified personnel, premises, and equipment;
presence of documentation describing the manufacturing process, parameters, quality indicators, methods for their determination, information on packaging, labeling, conditions of transportation and storage, and shelf life;
control at all stages of manufacturing.

Manufacturing of unregistered BMCP is not permitted, except for manufacturing for the purposes of preclinical and clinical trials and manufacturing of individual BMCP (Part 3 of Article 35 of Federal Law No. 180-FZ). Manufacturing of falsified BMCP and manufacturing in violation of good practice rules is prohibited (Part 5 of Article 35 of Federal Law No. 180-FZ).

Post-registration control over BMCP includes:

safety monitoring of BMCP carried out by the marketing authorization holder and Росздравнадзор (Article 41 of the Law on BMCP);
possibility of suspending product application (Article 42 of the Law on BMCP);
withdrawal from circulation and destruction of falsified, substandard, and counterfeit BMCP (Article 38 of the Law on BMCP);
also federal state control (supervision) in the field of BMCP circulation carried out by Росздравнадзор in accordance with Article 46 of the Law on BMCP and Decree of the Government of the RF No. 1062 dated June 30, 2021.

BMCP manufacturers may commercialize them, except for those specially manufactured for an individual patient directly in a medical organization:

to other BMCP manufacturers for manufacturing;
to scientific organizations, educational organizations for conducting scientific research;
to organizations carrying out medical activity (Part 7 of Article 35 of Federal Law No. 180-FZ).

Rules for commercializing BMCP are established by the Government of the Russian Federation (Part 8 of Article 35 of the Law on BMCP). We note that retail commercialization of BMCP to a patient is not provided by law, and independent application of BMCP by a patient is directly prohibited (Part 2 of Article 39 of the Law on BMCP): the product is applied in a medical organization by medical workers who have undergone training under an additional professional program on BMCP application issues (Part 1 of Article 39 of the Law on BMCP).

Specifics of Legal Regulation in the Eurasian Economic Union

Unlike Russian legislation, EAEU law has not yet adopted a separate act on biomedical cell products.

However, the Rules for Registration and Expertise of Medicinal Products for Medical Use, approved by Decision of the Council of the EEC No. 78 dated November 3, 2016 (the "Rules No. 78"), distinguish a special category – advanced therapy medicinal products (ATMPs), to which Section 17 of Part I of Appendix No. 1 to the Rules is dedicated. According to Clause 17.2 of Rules No. 78, ATMPs include three types of products:

gene therapy medicinal products (used to regulate, repair, replace, add, or delete a genetic sequence);
somatic cell therapy medicinal products, also known as somatic cell therapy products (contain cells or tissues that have been subjected to substantial manipulation, as a result of which their biological characteristics, physiological functions, or structural properties significant for clinical use are altered, or which are not intended to perform the same primary function in the recipient as in the donor);
tissue engineered products (contain cells or tissues and are intended to regenerate, repair, or replace human tissue).

Combined ATMP (a product that includes a medical device) is not named as a separate type in Clause 17.2 of Rules No. 78. Special requirements for the registration dossier are established for such products (in particular, Clause 17.3.4 of Rules No. 78). This is important during classification: a combined product belongs to one of the three listed types, while the presence of a medical device affects the scope of the dossier rather than the type affiliation.

The key qualifying criterion is "substantial manipulation". If cells have undergone cultivation, genetic modification, differentiation, sorting with changes in biological characteristics – this is an ATMP. The list of manipulations that are not considered substantial is provided in paragraph three of Clause 17.2.2 of Rules No. 78 (they include, in particular, grinding and treatment with solutions of antibiotics or antiseptics); when classifying a specific product, one should check directly against this list in the current version.

Registration Procedures for Advanced Therapy Medicinal Products in the EAEU

Rules No. 78 provide for two main registration procedures (Clause 20 of Rules No. 78):

mutual recognition procedure (the applicant registers the product in a reference state, whose expert report is then recognized by concerned states, allowing for the consistent expansion of the geography of circulation);
decentralized procedure (expertise is conducted simultaneously in the reference state and concerned states with coordination of positions, which provides simultaneous access to multiple markets).

The mutual recognition procedure can also be carried out solely in a reference state – for the purpose of circulating the product on the market of a single member state (national registration procedure, sub-clause "a" of Clause 21 of Rules No. 78). In addition, Rules No. 78 provide for the procedure of bringing the registration dossier of a product registered under national rules into compliance with Union requirements (Section XIII), as well as conditional registration (sub-section VII.III).

The registration procedure in the EAEU includes the following legally significant stages:

submitting an application to the reference state indicating concerned states;
dossier validation (completeness check). A negative result entails return without consideration on the merits; this is not a refusal of registration and does not preclude re-submission;
expertise – evaluation of quality, safety, efficacy, as well as inspection of the manufacturing site for compliance with GMP, if a valid conclusion is absent;
formation of an expert report by the reference state and sending it to concerned states;
review in concerned states, formation of remarks;
coordination of disagreements; if unresolved, consideration of the issue in the profile body of the Commission;
making a decision and entering information into the unified register.

Time limits set constraints: registration and expertise in the reference state must not exceed 140 business days from the date of submitting the application to the date of issuing the registration certificate (Clause 46 of Rules No. 78), and registration in a concerned state in the absence of disagreements – 60 business days (Clause 68 of Rules No. 78). The registration certificate for a newly registered product is issued for five years, upon expiration of which, upon confirmation of registration, an indefinite certificate is issued (Clause 18 of Rules No. 78). This is a noticeable difference from the BMCP regime, where an indefinite registration certificate is not provided and the confirmation procedure must be passed every five years.

Manufacturing of ATMPs is subject to the Good Manufacturing Practice Rules of the EAEU, approved by Decision of the Council of the EEC No. 77 dated November 3, 2016.

Key requirements:

aseptic manufacturing;
control of starting material of donor origin;
prevention of cross-contamination and mix-ups;
validation of transportation;
deviation management with a short shelf life.

Biological material donation and related bioethical issues are not systematically regulated by Union law and remain an area of national competence.

Of particular note is the Union analogue of the Russian individual BMCP regime. According to Clause 5.1 of Rules No. 78, advanced therapy medicinal products manufactured on a non-standardized (non-routine) basis and applied on the territory of the same member state in a treatment-and-prophylactic institution for the purpose of executing an individual medical prescription of a product specially manufactured for an individual patient do not require registration within the Union; manufacturing of such products is permitted by the authorized body of the member state. Member states are obliged to ensure equivalence of requirements for batch traceability and pharmacovigilance. The structure essentially coincides with the model of Article 32.1 of Federal Law No. 180-FZ and Decrees of the Government of Russia No. 384 and No. 385: not a product is permitted, but the activity of a specific medical organization.

Thus, the Russian legislator recognized the cell product as an independent legal object, which required a separate law. The Union integrated it into the existing system as a sub-type of a medicinal product. The former approach provides greater substantive precision (it is possible to regulate donation and bioethics in detail), while the latter provides greater systemic economy and compatibility with international practice. At the same time, the opposition should not be absolutized: in terms of individual (non-routine) manufacturing, both systems came to a similar decision, and after the exclusion of advanced therapy medicinal products from the concept of BMCP, the scope of Federal Law No. 180-FZ and Union law is separated rather than competitive.

Russian law is incomparably more detailed on issues of donation regulation. Union law practically does not touch upon these issues, leaving them to national competence, which increases the risk of disputes.

As for procedural issues, the Union procedure is administratively more complex, but opens the market of five states with a single action.

A promising direction for development is seen in the harmonization of requirements of Russian and Union legislation in the field of circulation of cellular and advanced therapy products, primarily in terms of donor standards, traceability, and requirements for non-routine manufacturing.

Liability for Violations of Legislation in the Field of BMCP Turnover

Traditionally, such types of legal liability as disciplinary, administrative, criminal, and civil liability are distinguished.

Article 47 of the Law on BMCP is of a reference nature: violation of legislation on BMCP circulation entails liability in accordance with the legislation of the Russian Federation. Special provisions directly naming biomedical cell products are not contained in either the CAO RF or the Criminal Code of the RF to date. It is indicative that the subject matter of Article 238.1 of the Criminal Code of the RF and Article 6.33 of the CAO RF are medicinal products, medical devices, and dietary supplements; BMCP are not named in the dispositions, and broad interpretation in criminal and administrative law is impermissible.

In this regard, one should keep in mind the possibility of liability arising for other punishable acts committed during the turnover of BMCP. For example, under Article 238 of the Criminal Code of the RF for rendering services that do not meet safety requirements, under Article 235 of the Criminal Code of the RF for illegal implementation of medical activity, Article 109 of the Criminal Code of the RF for causing death by negligence, Part 2 of Article 14.1 of the CAO RF for carrying out entrepreneurial activity without a license, Article 13.11 of the CAO RF for violating personal data legislation, etc. Published judicial practice of applying the listed provisions specifically to BMCP circulation as of the date of preparing каркаса article has not been identified.

As for civil liability, Article 48 of the Law on BMCP directly provides for the obligation to compensate for harm caused to the life and health of citizens for the BMCP manufacturer and for the organization where the BMCP is applied. Compensation for harm is carried out in accordance with the legislation of the Russian Federation (Part 3 of Article 48 of Federal Law No. 180-FZ), i.e., under the general rules of Chapter 59 of the Civil Code of the RF. When qualifying relations under the rules on harm caused by defects in goods, work, or services (Articles 1095–1098 of the Civil Code of the RF), harm is compensated regardless of fault; at the same time, Article 1098 of the Civil Code of the RF provides for grounds for exemption from liability, and Article 48 of the Law on BMCP itself requires proving specific circumstances – sub-standard quality of the product, unreliability of the instructions, or violation of instructions during application. Therefore, the premise of strict liability should be applied taking into account this distribution of the burden of proof.

The BMCP manufacturer is obligated to compensate for harm if the presence of one of the following circumstances is proven:

the BMCP was applied as intended 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 application of a sub-standard biomedical cell product;
the cause of harm to the life and health of citizens was unreliable information contained in the instructions for use of the BMCP.

The organization where the BMCP is applied is obligated to compensate for harm if it is proven that the cause of harm to the life and health of citizens was the application of BMCP in violation of the instructions for its use.

Published practice of applying Article 48 of the Law on BMCP as of the date of preparing the article has not been identified, which is logical given the negligible number of registered BMCP. Related issues, nonetheless, reach higher courts: for example, in Ruling of the Supreme Court of the RF No. 14-AD22-5-K1 dated February 8, 2023, handling of medical waste was considered, which by virtue of Part 1 of Article 49 of Federal Law No. 323-FZ also includes waste generated during the manufacturing and storage of biomedical cell products.

Summing up, we draw the following conclusions:

Cell products required the law to create a fundamentally new regulatory structure combining pharmaceutical law, legislation on donation, personal data protection, and bioethics. None of the existing models fit in pure form.
Russia and the EAEU chose different conceptual paths – a separate law versus a special category of medicinal products.
The supranational model wins in international compatibility and market reach, but loses in the detail of regulating donation and bioethical restrictions, leaving these issues to the discretion of member states.

Key problems common to national and supranational levels of regulation are currently as follows:

determination of the legal nature of biological material;
insufficient regulation of biobanking;
harmonization of donor standards at the Union level and mechanisms for financing patient access to high-cost therapy.

To them should be added two issues that escalated after the 2023–2024 reform: the consequences of termination of previously issued BMCP registration certificates starting January 1, 2026, and the time-limited nature of the individual BMCP regime established through September 1, 2030.

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References

Federal Law No. 466-FZ dated August 4, 2023, On Making Amendments to Article 4 of the Federal Law On the Circulation of Medicinal Products and Federal Law On Biomedical Cell Products.
Order of the Ministry of Health of Russia No. 569n dated August 28, 2017, On Approval of the Rules for Obtaining Biological Material for the Manufacturing of Biomedical Cell Products and Transferring It to the Manufacturer of Biomedical Cell Products.
Order of the Ministry of Health of Russia No. 842n dated October 20, 2017, On Approval of Requirements for the Organization and Activities of Biobanks and Rules for Storing Biological Material, Cells for Preparing Cell Lines, Cell Lines Intended for the Manufacturing of Biomedical Cell Products, Biomedical Cell Products.
Order of the Ministry of Health of Russia No. 512n dated August 8, 2018, On Approval of the Good Practice Rules for Working with Biomedical Cell Products.
Order of the Ministry of Health of Russia No. 669n dated September 22, 2017, On Approval of the Good Clinical Practice Rules for Biomedical Cell Products.
Order of the Ministry of Health of Russia No. 282n dated May 31, 2017, On Approval of the Procedure for Issuing a Permit to Conduct a Clinical Trial of a Biomedical Cell Product.
Order of the Ministry of Health of Russia No. 32n dated January 31, 2017, On Approval of the Procedure for Submitting Documents from Which the Registration Dossier for a Biomedical Cell Product Is Formed and the Form of Application for State Registration of a Biomedical Cell Product.
Decree of the Government of the RF No. 384 dated March 28, 2024, On Approval of the Rules for the Circulation of Biomedical Cell Products Intended for Executing an Individual Medical Prescription of a Biomedical Cell Product Specially Manufactured for an Individual Patient Directly in the Medical Organization Where This Biomedical Cell Product Is Applied.
Order of the Ministry of Health of Russia No. 512n dated August 8, 2018, On Approval of the Good Practice Rules for Working with Biomedical Cell Products.
Decree of the Government of the RF No. 1184 dated October 3, 2018, On Approval of the Regulations on Licensing the Activity of Manufacturing Biomedical Cell Products.