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EEC to Update Pharmaceutical Registration Rules in the EAEU

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As noted by Valery Afanasyev, Partner for GR & Risk at Baikal Lobridge, the amendments approved by the Eurasian Economic Commission (EEC) are aimed at harmonizing pharmaceutical registration procedures within the Eurasian Economic Union (EAEU) and enhancing transparency in regulatory processes.
“Applicants will have the opportunity to request the exclusion of confidential information from expert reports. Additionally, clear timelines and procedures for dossier review have been established, and document submission requirements have been standardized,” the expert emphasized.
The Board of the Eurasian Economic Commission (EEC) has approved the draft decision “On Amendments to the Rules for Registration and Expertise of Medicinal Products for Medical Use.” The directive No. 148 dated October 14, 2025, has been published on the EAEU legal portal.

The document aims to update the regulatory framework governing the circulation of medicinal products in the EAEU single market, including clarifications on the interaction between national competent authorities and expert organizations. The updated rules are expected to reduce the timelines for assessment of registration dossiers and strengthen trust between regulators and pharmaceutical market participants.

Further details are available in the article by Pharmvestnik.
2025-10-20 13:00