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Main  >  News  >  Changes have been made to the rules for inspecting foreign sites for GMP compliance

Changes have been made to the rules for inspecting foreign sites for GMP compliance

The decision of the Government of the Russian Federation will simplify the access of foreign drug manufacturers to the Russian market

Foreign drug manufacturers were able to more efficiently interact with Russian institutions that monitor compliance with good manufacturing practices (GMP), the decree on this dated September 5, 2020 No. 1361 was signed by the Chairman of the Government of the Russian Federation Mikhail Mishustin.

Checks for compliance of the production site with GMP requirements are carried out by the State Institute of Medicines and Good Practices (GILS and NP) of the Ministry of Industry and Trade of Russia. The department inspects foreign production facilities and generates reports, on the basis of which conclusions on GMP compliance are made, which are necessary for the registration of medicinal products.

Previously, foreign pharmaceutical manufacturers could confirm that they had eliminated the inconsistencies found during the inspection only during the next inspection. Now, if they are found, foreign companies will be able to submit a corrective action plan even before the inspection report is formed.

The adjustments approved by the Chairman of the Government will simplify the introduction of foreign medicines to the Russian market. The decision will also help bring Russian legislation in line with the Rules for Pharmaceutical Inspections, approved by the EEC Council.

The signed document amended the Government Decree of December 3, 2015 No. 1314.

 

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