In July of this year, the Eurasian Economic Commission published an announcement on its official website stating that unified EAEU regulations govern the registration of medicinal products effective July 1, 2021. The Council of the Economic Commission approved these regulations under Decision No. 78 dated January 3, 2017, “On the Rules for Registration and Examination of Medicinal Products for Medical Use.” Importantly, the Russian Federation implemented mandatory registration under the EAEU Rules earlier, effective January 1, 2021.

The core features of the transitions within the EAEU pharmaceutical registration framework include:

• Conducting scientific and pre-submission consultations: Prior to filing a marketing authorization application, competent authorities or expert organizations of the Member States may, upon the applicant’s request, provide scientific and pre-registration consultations regarding analytical testing, as well as preclinical and clinical trials, in compliance with national legislation;
• Navigating GMP compliance mandates: When submitting applications for registration, re-registration (confirmation), or alignment with EAEU frameworks, applicants must include a valid document within the registration dossier certifying compliance with EAEU Good Manufacturing Practice (GMP) standards;
• Evaluating non-EAEU preclinical data: Expert bodies review preclinical safety data generated outside the EAEU during the evaluation process, provided that the underlying studies were designed, conducted, and documented in accordance with Good Laboratory Practice (GLP) requirements equivalent to EAEU standards;
• Managing statutory timelines: The timeframe for the registration and expert evaluation of a medicinal product in the reference Member State shall not exceed 210 calendar days from the application submission date to the final issuance of the marketing authorization.

As a matter of regulatory history, prior to July 1, 2021, applicants retained the option to seek market access either under the unified EAEU Rules or via the domestic legislative frameworks of individual Member States.

All EAEU jurisdictions concluded the inaugural phase of the transition to a unified registration system on July 1, 2021.

Nevertheless, pharmaceutical products currently holding valid national registrations may remain in circulation until the end of 2025. To safeguard market access after 2025, manufacturers intending to distribute these medicinal products within the EAEU territory must update and align their registration dossiers with the EAEU registration and expert examination rules. Consequently, market participants must anticipate that all marketing authorizations issued under the domestic regulations of individual Member States will expire upon their stated completion date, and in no event later than December 31, 2025.