Russian government to start checks for GMP compliance of domestic drug producers

The Russian government plans to start massive checks of the domestic producers of drugs, as well as drug importers for their compliance of products with Good Manufacturing Practices (GMP) standards, which became mandatory in Russia since the beginning of the current year, according to an official representative of the Russian Ministry of Industry and Trade.

It is planned that all the checks will be completed by 2018. According to the Industry and Trade Ministry, at present only 80% of drugs in value terms and 67% by volume produced by the enterprises comply with GMP standards.

According to Olga Kolotilova, director of the Department of Development of Pharmaceutical and Medical Industry of the Russian Ministry of Industry and Trade, these state plans will be stipulated in the existing federal law “On the Turnover of Drugs in Russia."

According to Ms Kolotilova, one of the possible options is mutual recognition of the results of such drug audits, which is expected to be achieved through the signing of inter-country agreements.

According to state plans, if importers are not able to confirm the quality of the supplied drugs with GMP standards their further imports will be prohibited. At the same time in the case of domestic producers, this will result in the withdrawal of licenses.

Source