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We are pleased to present the Russian Pharmaceutical Industry Regulatory Digest for the third quarter of 2025.
Among the most significant regulatory updates in the Russian pharmaceutical and life sciences sector during Q3 2025 are the following:
- Introduction of the concept of “strategically important medicines” alongside a draft framework for establishing the corresponding list.
- Establishment of a regulatory procedure for physicians prescribing dietary supplements to patients.
- Amendments to the EAEU Good Clinical Practice Rules, eliminating reporting requirements for serious unexpected adverse reactions to placebos and clarifying investigator and sponsor obligations.
- Updates to the Good Pharmacy Practice Rules to reflect current enforcement standards.
- Reduction of statutory timelines for approving or denying marketing authorizations for medicines.
- Prohibition on pharmacies selling medicines whose use has been suspended or whose tracking system integration has been blocked.
- Revision of the regulations governing the registration and calculation of maximum manufacturer selling prices for Vital and Essential Drugs (VED).
- Tightening of dispensing requirements for medicines subject to heightened medical supervision under the revised drug dispensing rules.
- Clarification of quality control system requirements within the updated Rules for the Storage of Medicines.
- Enactment of a mechanism for the voluntary submission of information to the “Chestny Znak” track-and-trace system.
The digest provides a comprehensive review of the aforementioned updates as well as other equally critical legal developments.
