The Ministry of Industry and Trade of Russia has prepared a draft government resolution proposing that, as of March 1, 2026, certain provisions of regulatory acts granting the ministry authority to confirm compliance of pharmaceutical manufacturers with Good Manufacturing Practice (GMP) requirements under national rules be declared invalid. This is another step toward formalizing the final transition to the Eurasian inspection system.
Previously, the government declared the national rules for inspecting pharmaceutical manufacturers for GMP compliance invalid. Government Resolution No. 1314 governing the inspection procedure was repealed, as well as Resolutions No. 789 and No. 1361, which amended the rules for assessing manufacturing compliance with GMP requirements, and Item 36 of the list of public services related to inspections of foreign pharmaceutical manufacturing sites. As of March 1, 2026, manufacturing inspections and the issuance of conclusions will be carried out exclusively in accordance with EAEU GMP rules.
Against this background, the draft prepared by the Ministry of Industry and Trade excludes from the Regulation on the Ministry several subparagraphs that had закрепляли the ministry’s functions related to organizing national GMP inspections, issuing conclusions on manufacturing compliance with GMP requirements, and conducting related procedures.
At the same time, it is proposed to exclude provisions of Resolution No. 1025, which in 2015 expanded the powers of the Ministry of Industry and Trade in the field of national GMP inspections—from organizing manufacturer inspections to issuing compliance conclusions.
These adjustments bring the regulatory framework into line with Federal Law No. 304-FZ, which formalized the transition from the national GMP model to mandatory compliance with EAEU GMP rules.
As noted in the explanatory memorandum, the draft is technical in nature: it eliminates remaining references to the ministry’s powers in the area of national GMP control and does not introduce new requirements for manufacturers. The document completes the alignment of the regulatory framework with a unified Eurasian inspection model.
Work on creating a unified inspection system at the EAEU level has been underway since 2015, when the Eurasian Economic Commission (EEC) began developing common approaches to controlling pharmaceutical manufacturing. In 2020, the procedures for Eurasian pharmaceutical inspections were approved domestically by a resolution of the Government of the Russian Federation, marking an important stage in the transition to unified GMP requirements within the Union.
Later, the EEC allowed GMP inspections to be conducted remotely using audio and video communication, making it possible to continue inspections during the COVID-19 pandemic and reduce costs for participants. During the same period, the Ministry of Industry and Trade began aligning the list of pharmaceutical manufacturing operations with international practice, and as of July 1, 2020, Russian regulation established the priority of EAEU GMP rules over national standards.
Source: Vademecum, December 3, 2025.
