On March 1, 2026, Russia will complete its transition to the unified system of Good Manufacturing Practices (GMP) of the Eurasian Economic Union (EAEU). National regulations for inspecting foreign pharmaceutical manufacturers will be completely abolished.
In connection with this, three previously valid decrees of the Government of the Russian Federation (No. 1314, No. 789 and No. 1361) are no longer in effect.
The key changes are as follows:
* All inspections of pharmaceutical production will now be regulated exclusively by EAEU standards.
* The Eurasian Economic Commission has approved an updated inspection planning methodology. It is based on a risk-based approach that involves an individual assessment of each production facility.
* Depending on the results of the assessment, the frequency of inspections, their depth and scope will be determined.
* Manufacturers will be issued EAEU GMP certificates, the validity of which may vary.
The issuance of new certificates confirming compliance with Union standards began on November 14 of this year.
