GMP Registry: New Certificates Issued and Refusals in January 2026

On January 26, the Ministry of Industry and Trade of Russia updated the GMP certificates database. Between January 16 and 20, 2026, the regulator made decisions regarding a number of manufacturing sites. The update affected both Russian manufacturers and facilities of international pharmaceutical companies.

Certificates Issued (January 16–20, 2026)

Positive decisions were made regarding 13 sites. The geography of issued certificates covers Russia, EU countries (Germany, France, Italy, Netherlands, Greece), Serbia, and India.

Refusals to Issue Certificates

During the reporting period, 5 decisions to refuse certificates were issued. Negative verdicts were received by applicants from Russia, India, and Syria.

Brief Overview of Changes

1. Import Stability. Synchronous certification of Big Pharma sites (Sanofi, GSK, Abbott, Janssen) indicates that regulatory mechanisms for interaction with European manufacturers continue to operate in normal mode.
2. Medical Gases Manufacturers. The registry continues to be replenished with specialized industrial enterprises. Successful inspection of such sites as NLMK and Pskov Nitrogen-Oxygen Plant confirms the industry’s systematic work on complying with licensing requirements for medical oxygen production.
3. Unified Requirements. Refusals received by major players (such as the Russian “R-Pharm” and foreign partners) testify to the inspectorate’s strict approach to commissioning new production lines regardless of the applicant’s status and scale.

Previously on the topic: First Issued GMP Certificates and Refusals in 2026

Source: Unified Register of Drug Manufacturers