The Russian government passed a resolution allowing foreign pharmaceutical manufacturers to interact more quickly with Russian control agencies.
Inspections of foreign manufactures and preparation of reports are carried out by the Federal State Institution «State Institute of Drugs and Good Practices». On the basis of these documents, conclusions on compliance are made, which are necessary for the registration of medicinal products in Russia.
Prior to the adoption of the resolution, foreign pharmaceutical companies could confirm the elimination of the discovered deficiencies only during the next inspection. From now on, in the event of non-compliance, foreign manufacturers will be able to submit a corrective action plan even before the inspection report is generated.
The government expects that such changes will facilitate the entry of foreign medicines into the Russian market. Also, Russian legislation were brought into line with the Rules for Conducting Pharmaceutical Inspections of the Eurasian Economic Union.