How the regulation is built
The foundation is the Law “On the Circulation of Medicines”. The general rules for conducting trials (Good Clinical Practice and bioequivalence studies) are common to the countries of the Eurasian Economic Union (EAEU) and are set by decisions of the Council of the Eurasian Economic Commission (EEC). The procedure for obtaining a permit, ethics review and insurance is set by national law; in Russia, that is Law No. 61-FZ. The Law refers to them directly: trials are conducted under the Good Clinical Practice (GCP) rules approved by the EEC (Article 38, Part 1.1), and bioequivalence studies under the procedure set by EAEU law (Article 38, Part 2). Ministry of Health orders add the details of ethics review, lists and registers.
Checked on 21 October 2026. The text of the Law is taken from the ConsultantPlus reference system (version of 4 August 2026): the official portal publishes original texts and amending acts but not consolidated versions. Amendments of 2024–2026 were taken from that system and spot-checked against the official texts of the amending laws. EEC decisions and Ministry of Health orders were checked against the texts of the acts.
The documents and what they contain
| Document | What it regulates |
|---|---|
| Federal Law No. 61-FZ of 12 April 2010 “On the Circulation of Medicines” | Definitions (Art. 4), the conduct of trials (Art. 38), permit and ethics review (Art. 39, 39.1), conduct of a trial (Art. 40), participants’ rights (Art. 43), compulsory insurance (Art. 44) |
| EAEU Bioequivalence Rules — EEC Council Decision No. 85 of 3 November 2016 | Study design, number and selection of subjects, data analysis, the report. Amended by Decisions No. 67 (2020), No. 22 (2023) and No. 30 (2024) |
| EAEU Good Clinical Practice Rules — EEC Council Decision No. 79 of 3 November 2016 as restated by Decision No. 63 of 1 August 2025 (in force since 10 March 2026) | Rights and safety of participants, the ethics committee, informed consent, duties of the investigator and sponsor, trial documents. Based on ICH guideline E6(R2) |
| Ministry of Health Order No. 586n of 31 October 2024 (in force since 1 January 2025) | The Ethics Council: composition, procedure, ethics review and the forms of its opinions |
| Ministry of Health Order No. 706n of 20 December 2024 | How the list of medical organisations conducting clinical trials and the register of permits are published |
| Government Resolution No. 714 of 13 September 2010 | Model rules of compulsory life and health insurance for trial participants |
What the Law says about participants
- Participation is voluntary, and a person may withdraw at any stage of the trial (Art. 43, Parts 1 and 4).
- The participant is informed in advance, in writing, about the medicine and the essence of the trial, safety and degree of risk, terms of participation, purpose and duration, what to do if something unexpected happens, the terms of compulsory insurance and the guarantees of confidentiality (Art. 43, Part 2).
- Consent is confirmed by a signature on the patient information sheet (Art. 43, Part 3). The sheet may be on paper or an electronic document (Art. 4, item 49).
- The Law prohibits trials involving orphans and children left without parental care, pregnant and breastfeeding women, military personnel, law-enforcement officers, persons serving a prison sentence and persons held in pre-trial detention. For some groups there are provisos, for example for medicines intended specifically for pregnant and breastfeeding women, subject to the conditions the Law lists (Art. 43, Part 6).
- Participation is impossible without a compulsory life and health insurance contract for the participant (Art. 44, Part 14). The amounts of the insurance payments are set by the Law (Art. 44, Part 5), and the policyholder is the organisation that obtained the permit to organise the trial (Art. 44, Part 1).
More for participants on the page “Informed consent”.
What is needed before a trial can start
- Ministry of Health permit. A trial is conducted on the basis of a permit issued after an expert review of the documents and an ethics review (Art. 38, Part 4; Art. 39, Part 1).
- Ethics review. It is carried out by the Ethics Council set up by the Ministry of Health (Art. 39.1). The Council receives the protocol, the investigator’s brochure, the patient information sheet, information on the investigators’ experience and a copy of the insurance contract. The expert review of the documents and the ethics review take no more than 25 working days (Art. 39, Part 6); before them the Ministry checks the documents submitted, which takes up to three working days (Part 3), and after the opinions it takes its decision within up to three working days (Part 7).
- Insurance of participants. The policyholder is the organisation that obtained the permit to organise the trial (Art. 44, Part 1). A copy of the compulsory insurance contract stating the maximum number of participants is part of the package for the permit (Art. 39, Part 2, item 9), so the contract is concluded before the application is filed.
- Contract with the medical organisation. The trial is conducted under a contract between the organisation that obtained the permit and the medical organisation (Art. 41).
- The investigator. The head of the medical organisation appoints an investigator with a medical specialty matching the trial and at least three years of experience in clinical trial programmes (Art. 40, Part 1).
- Start of the trial. The head of the organisation notifies the Ministry of Health of the start within no more than three working days (Art. 40, Part 3.1). Participants may be enrolled only after the ethics committee’s written approval (EAEU GCP Rules, clauses 3.3.6 and 4.4.1).
Rules for bioequivalence studies
For generic medicines the Law provides for bioequivalence and (or) therapeutic equivalence studies (Art. 38, Part 2). The design, the number of participants, the selection criteria and the content of the report are set by the EAEU Rules: the standard design is a randomised two-period crossover study (clause 15), at least 12 subjects are included in the analysis (clause 26), and studies are conducted in healthy volunteers except where the medicine poses an obvious threat to their health and such a study would be unethical (clause 27). A detailed guide is in “EAEU rules for bioequivalence studies”.
Accreditation and the list of organisations
The former procedure for accrediting medical organisations to conduct clinical trials (Government Resolution No. 683 of 3 September 2010) ceased to apply on 1 January 2021 (Resolution No. 855 of 13 June 2020). The Law in force has no separate procedure for accrediting medical organisations to conduct clinical trials of medicines: the Ministry of Health publishes a list of medical organisations conducting clinical trials and a register of permits issued (Art. 38, Part 8; Order No. 706n).
Where to check a clinic in the open registers
| What to check | Where |
|---|---|
| Medical licence: number, date, addresses, types of work | Unified Licence Register — Roszdravnadzor |
| Permits for clinical trials | Register of clinical trial permits — GRLS |
| Organisations conducting clinical trials | GRLS: information on organisations conducting clinical trials |
| Principal investigators | GRLS: investigator register |
| Personal-data operator status | Register of operators — Roskomnadzor |
Do not confuse the registers. The site cr.minzdrav.gov.ru (formerly cr.rosminzdrav.ru) is the electronic rubricator of clinical guidelines, not a register of clinical trials. The trial registers are in GRLS: grls.minzdrav.gov.ru.
Sources
- Federal Law No. 61-FZ of 12 April 2010 — text on ConsultantPlus; amendments: Law No. 1-FZ of 30 January 2024, Law No. 504-FZ of 28 December 2025.
- EEC Council decisions: No. 85 of 3 November 2016, amendments No. 67, No. 22, No. 30; No. 79 of 3 November 2016 and No. 63 of 1 August 2025.
- Ministry of Health orders: No. 586n, No. 706n, No. 274n (repeal of Order No. 200n from 1 September 2024).
- Government Resolution No. 855 of 13 June 2020 (the accreditation rules ceased to apply on 1 January 2021).
Questions and answers
Which documents govern clinical trials in Russia?
Federal Law No. 61-FZ of 12 April 2010 “On the Circulation of Medicines” (Articles 38–44 cover clinical trials), the EAEU Good Clinical Practice Rules (EEC Council Decision No. 79 as restated by Decision No. 63), the EAEU Bioequivalence Rules (EEC Council Decision No. 85) and Ministry of Health orders, for example No. 586n on ethics review and No. 706n on the list of organisations conducting trials.
Does Russia have national GCP rules?
There are no mandatory national GCP rules: Ministry of Health Order No. 200n was repealed by Order No. 274n with effect from 1 September 2024. The Law (Article 38, Part 1.1) provides that trials are conducted under the Good Clinical Practice Rules approved by the Eurasian Economic Commission.
How can I check that a clinic holds a licence and trial permits?
A medical licence is looked up in the Unified Licence Register on the Roszdravnadzor website; trials in which the clinic takes part as a site, in the permit register of the State Register of Medicines (GRLS, grls.minzdrav.gov.ru; searchable by the organisation conducting the trial); principal investigators in the GRLS investigator register. The addresses are given on this page.
This material is for information only and is not legal advice. The rules are cited as of the date of the last update; check the current versions of the documents before making decisions.
See also
EAEU rules for bioequivalence studies: a short guide
The EAEU Rules for Conducting Bioequivalence Studies (EEC Council Decision No. 85 of 3 November 2016) set the study design, the number and selection of volunteers, data analysis and the content of the report. The standard is a two-sequence crossover study, with at least 12 subjects in the analysis.
Learn more
Informed consent: what to know before you sign
Informed consent is a document you sign after a doctor has explained the study in detail: its aims, procedures, risks, benefits and your rights. Sign it only when everything is clear.
Learn more
Clinic licences and permits
The clinic conducts clinical studies under a licence for medical activities and in line with the principles of Good Clinical Practice (GCP) and its own standard operating procedures.
Learn more