As of June 21, the updated Rules for the Registration and Examination of Medicinal Products for Human Use in the Eurasian Economic Union (EAEU), approved by the Council of the Eurasian Economic Commission (EEC), have come into effect, the EEC press service reported.
“The new provisions are aimed at harmonizing the registration processes across EAEU member states, completing the transition to unified union requirements, and ensuring uninterrupted patient access to medicines,” the statement reads.
“The changes relate to the procedure for aligning medicinal product registration dossiers with EAEU requirements, and to pharmaceutical inspections of manufacturers initiated during registration procedures. To accelerate the transition to EAEU regulation, restrictions have also been lifted on simultaneously conducting mutual recognition procedures and making amendments to a medicinal product’s registration dossier,” the EEC clarified.
“These amendments are a significant step toward completing the transition to a unified approach to drug registration within the Eurasian Economic Union. Our goal is to minimize administrative barriers for manufacturers while protecting the interests of patients, who must receive high-quality and safe medicines,” commented Valentin Tataritsky, EEC Minister for Technical Regulation, as quoted by the commission’s press service.
Source: Interfax, July 21, 2025
