Russia plans 16 GMP inspections of foreign veterinary drug manufacturers for 2027
Speaking at FeedVetGrain 2026, Rudnyaev said that 27 inspections had already been conducted abroad during 2026. Some of the facilities inspected did not meet good manufacturing practice (GMP) requirements. The inspection process is still ongoing for 16 sites, including the review of corrective and preventive action (CAPA) plans. Inspections of another eight facilities are scheduled before the end of the year.
According to the representative of the All-Russian State Centre for Quality and Standardisation of Veterinary Drugs and Feed (VGNKI), the number of inspection visits in 2027 could exceed the planned total, as manufacturers can still submit applications. He presented this information at a roundtable on Decision No. 1 and the re-registration of medicinal products under the new rules of the Eurasian Economic Union (EAEU).
Rudnyaev noted that the number of inspections declined in 2023–2025. He suggested that this trend might be linked to the political situation and the reluctance of some foreign companies to supply medicines to the Russian market. In his assessment, the situation has now stabilised somewhat.
A new pharmaceutical inspection procedure has been in effect since March 1, 2026. The Federal Service for Veterinary and Phytosanitary Surveillance (Rosselkhoznadzor) was granted authority to inspect manufacturing operations and issue GMP certificates. Key changes include joint inspections of foreign facilities involving the competent authorities of EAEU countries.
The inspections assess manufacturing sites’ compliance with GMP requirements. If non-compliances are identified, the company may submit a corrective and preventive action plan, together with evidence of its implementation. Following a review of the inspection documentation, a final decision is made on whether to issue or refuse a certificate.
Rudnyaev also addressed the revised requirements for sterile manufacturing. The updated annex to the GMP rules will take effect on December 28, 2026. A transition period until 2029 has been established for certain requirements whose implementation entails substantial reconstruction of manufacturing sites. According to the VGNKI representative, inspections in 2027 will take account of the updated requirements and the new procedure for cooperation between the competent authorities of EAEU member states.
