According to Vyacheslav Kharitonov, Regulatory Risk Assessment Expert at Baikal Communications Group, the amendments to the rules governing the registration and expert evaluation of medicinal products adopted by the Council of the Eurasian Economic Commission are aimed at strengthening trust in the supranational regulatory framework and safeguarding applicants’ sensitive information.

“A substantial amount of confidential data — including commercial secrets — is currently consolidated within a unified information framework. Therefore, ensuring an adequate level of trust in the new procedures is critically important for the EEC. One of the subsequent stages in developing the regulatory environment may involve establishing an analogue of the European Medicines Agency (EMA), which would assume responsibility for coordinating scientific evaluation and marketing authorization processes,” Kharitonov emphasized.

The Council of the Eurasian Economic Commission has approved amendments to the rules for the registration and expert evaluation of medicinal products within the EAEU. Decision No. 93 dated 26 November 2025 has been published on the EEC legal portal.

The document introduces the term “confidential data,” which includes information protected as a commercial secret, such as details on manufacturing processes, inspection results, registration strategies, and production sites. Applicants will be able to request the exclusion of such data from publicly available expert reports, thereby safeguarding their competitive advantages.

In addition, the amendments revise the classification of variations to registration dossiers, clarify the procedures for scientific and regulatory evaluation, specify requirements for dossier composition, and harmonize documentation rules for medicinal product registration across the EAEU.

The adopted changes are intended to modernize the regulatory framework governing the circulation of medicinal products in the Union’s common market and to support the development of a more resilient supranational regulatory model for the pharmaceutical sector.

Further details are available in the Pharmvestnik.

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