New Changes Approved for GMP Certificate

The Rules for organizing and conducting inspections of drug manufacturers for compliance with the requirements of the Good Manufacturing Practice (GMP) rules, as well as for issuing conclusions on the compliance of the drug manufacturer with the specified requirements are amended recently. Approving these changes, the Government Decision of the Russian Federation of May 29, 2020 No. 789 was published on the portal on June 2, 2020.

Read more
GMP inspections on-site are temporary stopped

The Russian state GMP-inspectorate temporarily decided to perform only the documentary inspection of foreign drug manufacturers taking into account the corrective and preventive actions provided by the manufacture, as it was announced by the State Institute of Drugs and Good Practices.

Read more
EAEU approved unified rules for specifying the shelf life of drugs

February 26, Moscow 2020 -  Eurasian Economic Commission approved guidelines for calculating the start date of the shelf life of finished dosage forms of drugs for medical use and veterinary drugs. The recommendation comes into force 6 months after the date of its publication.

Read more