The framework in brief
Clinical trials of medicines in Russia are governed by Federal Law No. 61-FZ “On the Circulation of Medicines” (Articles 38–44). The law refers to rules common to the Eurasian Economic Union (EAEU): trials follow the Good Clinical Practice (GCP) Rules approved by the Eurasian Economic Commission, and bioequivalence studies follow the EAEU Bioequivalence Rules. There is no separate national GCP order: Ministry of Health Order No. 200n was repealed from 1 September 2024. The GCP Rules are based on ICH guideline E6(R2), and their aim is the mutual recognition of data by the authorities of the EAEU member states.
From idea to first participant
- Permit holder. The trial is organised by the developer of the medicine or a person it authorises, or by a higher-education, supplementary-professional-education or scientific organisation (Article 38, Part 3). This party applies for the permit, concludes the insurance contract and signs the contract with the medical organisation (Articles 41 and 44).
- Documents. The application includes, among other documents, the protocol, the investigator’s brochure, the patient information sheet, information on the investigators’ experience, information on the composition and quality of the medicine, the non-clinical data and a copy of the insurance contract with the maximum number of participants (Article 39, Part 2).
- Review and permit. The Ministry of Health issues the permit after the expert review of the documents and the ethics review by the Ethics Council set up by the Ministry (Article 39.1; Order No. 586n). If the material is insufficient, the Ethics Council sends the applicant a request (an expert may not request materials directly); the applicant has up to 90 working days to answer, and that time is not counted in the ethics review period (Article 39.1, Parts 4.1–4.2). The Ministry also checks the documents for up to three working days beforehand and decides on the permit within up to three working days afterwards (Article 39, Parts 3 and 7).
- Insurance. A compulsory life and health insurance contract must be in place; without it a participant may not take part (Article 44, Part 14). The contract runs at least as long as the trial (Part 7).
- Site and investigator. The head of the medical organisation appoints an investigator with a matching specialty and at least three years of experience in clinical trial programmes (Article 40, Part 1).
- Start. The head of the organisation notifies the Ministry within no more than three working days of the start (Article 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).
Requirements for the site
- A medical licence. A clinical trial is conducted in a medical organisation, that is, a legal entity carrying out medical activity under a licence. Licences are checked in the Unified Licence Register on the Roszdravnadzor website.
- No separate accreditation. The former accreditation of medical organisations for clinical trials of medicines ceased to apply on 1 January 2021 (Government Resolution No. 855 of 13 June 2020). The Ministry of Health publishes the list of medical organisations conducting trials and the register of permits on its official website (Article 38, Part 8; Order No. 706n); the register of permits can be searched in the State Register of Medicines (GRLS).
- Resources. Under the GCP Rules the investigator can show the ability to recruit the required number of suitable subjects, has the time, qualified staff and material resources (premises and equipment), and provides the necessary medical care for adverse events during and after participation (clauses 4.2 and 4.3).
- Records of investigators. The Ministry keeps a register of investigators conducting or having conducted trials.
Participants
The law bars trials involving orphans and children left without parental care, pregnant and breastfeeding women, military personnel, law-enforcement officers, and prisoners and persons in pre-trial detention, with provisos for some groups (Article 43, Part 6). Participation is voluntary and can be ended at any stage. Healthy volunteers may take part in studies of safety and tolerability, with an exception for medicines produced outside Russia (Article 38, Part 1, item 1); how this applies to a particular medicine should be established before planning. The ethics committee reviews the amount and procedure of payments, which must be stated in the informed consent (GCP Rules, clauses 3.1.8–3.1.9).
Bioequivalence studies
For generic medicines the law provides for bioequivalence and (or) therapeutic equivalence studies under EAEU acts (Article 38, Part 2). The Bioequivalence Rules set the standard design (a randomised two-period crossover study in two sequences, clause 15), the number of subjects (justified by a calculation, with at least 12 in the analysis, clause 26) and the rules for selecting subjects: healthy volunteers aged at least 18 (clauses 27–28). A detailed guide is in “EAEU rules for bioequivalence studies”; the number of volunteers can be estimated in the calculator.
How to check a site
| What to check | Where |
|---|---|
| Medical licence | Unified Licence Register — Roszdravnadzor |
| Trial permits | GRLS register of clinical trial permits |
| Organisations conducting trials | GRLS: information on organisations conducting clinical trials |
| Principal investigators | GRLS: investigator register |
How we can help
If you are planning a study in Russia, send a synopsis or protocol: we will assess feasibility at the site, including a realistic number of volunteers and recruitment timelines. How we organise projects is described in “How we work”.
Sources
- Federal Law No. 61-FZ of 12 April 2010 “On the Circulation of Medicines”, Articles 38–44 — text on ConsultantPlus.
- EAEU Good Clinical Practice Rules — EEC Council Decision No. 79 as restated by Decision No. 63 (in force since 10 March 2026).
- EAEU Bioequivalence Rules — EEC Council Decision No. 85.
- Ministry of Health orders: No. 586n (Ethics Council), No. 706n (list of organisations and register of permits), No. 274n (repeal of the national GCP order).
- Government Resolution No. 855 of 13 June 2020.
Questions and answers
Do I need a permit to run a clinical trial in Russia?
Yes. A clinical trial is conducted on the basis of a permit issued by the Ministry of Health after an expert review of the documents and an ethics review (Article 38, Part 4; Article 39, Part 1 of Law No. 61-FZ). The expert review and the ethics review take no more than 25 working days (Article 39, Part 6); the Ministry’s initial check of the documents and its decision on the permit take up to three working days each (Parts 3 and 7). The time between the Ethics Council’s request and the applicant’s answer is not counted in the ethics review period (Article 39.1, Part 4.2).
Who can apply for the permit?
The trial may be organised by the developer of the medicine or a person authorised by it, as well as by higher-education, supplementary-professional-education and scientific organisations (Article 38, Part 3). A foreign developer may act as the organiser or authorise another person to do so, for example a contract research organisation (Article 38, Part 3).
Is there a separate accreditation of clinics to conduct trials?
Not for clinical trials of medicines in the legislation in force. The former accreditation rules (Government Resolution No. 683) ceased to apply on 1 January 2021. The Ministry of Health publishes a list of medical organisations conducting clinical trials and a register of the permits issued.
Which rules govern bioequivalence studies?
The EAEU Rules for Conducting Bioequivalence Studies (EEC Council Decision No. 85 of 2016, as amended) together with the EAEU Good Clinical Practice Rules. The standard design is a two-period, two-sequence crossover study; at least 12 subjects must be in the analysis.
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
Regulatory framework: the rules for clinical trials and bioequivalence studies in Russia and the EAEU
Clinical trials in Russia are governed by Federal Law No. 61-FZ “On the Circulation of Medicines”, the Good Clinical Practice Rules and the Bioequivalence Rules of the Eurasian Economic Union (EAEU), and orders of the Ministry of Health. This page shows what each document contains and which open registers let you check a clinic.
Learn more
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 moreFeasibility assessment of a clinical study
A feasibility assessment is a review of the protocol before a study starts. It shows whether the study can be run at the site within the required timelines and with the required number of participants. The clinic carries out this assessment for sponsors and contract research organisations (CROs).
Learn more