On July 27, 2026, the Russian Ministry of Health published a regulation detailing the procedure for obtaining approval to conduct clinical trials (CTs) of medicinal products for human use. The document systematizes all stages—from the list of required documents and fees to the review timeframe. Applications are submitted through the State Register of Medicines (GRLS) or the Unified Portal of State Services (UPGS).
Legal basis and amount of duties
The regulations were developed in accordance with Federal Law No. 61 – FZ , Article 333.32.1 of the Tax Code. code , and Also acts EEC — Solution Council dated 03.11.2016 No. 79 ( GCP Rules ) and Recommendation Collegiums from 27.12.2022 No. 49 ( requirements To quality studied drugs ).
The amount of the state duty is:
– 135,000 rubles – for the examination of standard and post-registration clinical trials;
– 210,000 rubles – for the examination of international multicenter clinical trials;
– 5,000 rubles – for issuing a permit.
The Ministry of Health verifies the fact of payment within the framework of interdepartmental cooperation.
Requirements for submitted materials
The registration dossier includes:
– clinical trial protocol and investigator’s brochure (for drugs registered in the EAEU, replacement with a general characteristic of the medicinal product is permitted);
– patient information leaflet and information on the researchers’ qualifications;
– a copy of the patient insurance contract indicating their maximum number;
– documents confirming the production license (for Russian sites) or a GMP compliance certificate (for foreign sites);
– quality documentation (with the exception of biological products, for which separate EEC rules apply).
The Ministry of Health also notes that the State Duma has already adopted amendments to Federal Law No. 61 , which establish requirements To data preclinical research And materials By quality .
Application review deadlines
– Initial verification of the completeness of documents – 3 working days.
– Expertise (including ethical) – 25 working days.
– When submitting a request for revision, the applicant is given up to 90 business days to respond; the decision-making period is suspended.
– Final decision and entry into the register – 3 working days after receiving expert opinions.
Grounds for refusal
At the application acceptance stage, a refusal is possible if the package of documents is incomplete, there is no confirmation of payment of the fee, or a response is not provided within the established 90 – day period. term . On stage issuance permissions refusal Maybe follow only on basis negative conclusions expert commissions or Council By ethics .
Significance for market participants
The new regulations increase the transparency of the procedure for sponsors of clinical trials and harmonize Russian requirements with the GCP rules of the EAEU, which is particularly relevant for the organization of international multicenter trials.
