The Eurasian Economic Commission’s Expert Committee on Medicines, chaired by Minister for Technical Regulation Alexander Subbotin, recommended the approval of a number of regulations aimed at unifying approaches to the registration and quality control of medicines in the Union countries. The documents are scheduled for review by the EEC Board between August and October 2026.
1. Uniform names of active substances in the registers
Amendments to the Rules for Registration and Expertise of Medicines have been approved. The amendments provide for standardized indication of active substance names in application forms and the unified register of registered drugs, linking them to the international nonproprietary, generic, common, or chemical name. This will eliminate ambiguous interpretation of data and improve information transparency within the EAEU common market.
2. Microbiological monitoring of the production environment: uniform standards
For the first time at the Union level, a draft recommendation for organizing microbiological cleanliness monitoring in pharmaceutical companies has been developed and approved. The document covers manufacturers of both sterile and non-sterile products, establishing harmonized requirements for monitoring the production environment.
3. Innovations in bioequivalence studies
Amendments have been made to the Rules for Conducting Bioequivalence Studies. The key innovation is the approval of model systems based on artificial membranes for assessing the bioequivalence of soft dosage forms (gels, ointments, and other topical products). This will eliminate costly and labor-intensive testing on donor skin, reducing manufacturers’ costs and accelerating the process of drug launch.
Impact on the pharmaceutical market
The adopted initiatives are aimed at systematically optimizing research and registration procedures, reducing the administrative burden on businesses, and establishing unified requirements for the quality and safety of medicines in the EAEU. Standardizing terminology, introducing alternative testing methods, and unified control standards create a predictable regulatory environment for developers and manufacturers, facilitating faster patient access to effective therapy.
