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Main  >  News  >  The Ministry of Industry and Trade of the Russian Federation makes the case for the registration of the drugs from abroad.

The Ministry of Industry and Trade of the Russian Federation makes the case for the registration of the drugs from abroad.


The Ministry of Industry and Trade monitors compliance of GMP-manufacturers who had generated documents for the first registration of drugs in Russia. This fact was noted by Sergey Tsyb, Deputy Minister of Industry and Trade.

Prior to that, Vladimir Shipkov, director of the Association of International Pharmaceutical Manufacturers (AIPM) said that beginning with January 1, 2016, foreign companies would not be able to register new pharmaceutical products in the Russian Federation without Russian GMP certificate.

Many experts have noticed that foreign drugs may come to the domestic market, but only if the introduction of certification requirements would be delayed by the Government.

Sergey Tsyb said he did not see any problems with compliance to the timing of inspections, and the powers will be exercised taking into account the existing capacities. His specialists are ready to fully exercise their powers and confirm their compliance with all requirements of the registration procedures for drugs, as well as to pass inspections for compliance with Russian Federation requirements within the framework of GMP standards during the initial registration of these drugs in the Russian Federation.

Until 2017, inspections for the purpose of re-registration of drugs were not required. In 2016, inspections applied only to foreign pharmaceutical manufacturers who registered their drugs in Russia for the first time. And up to 2017, a pharmaceutical product check was not required for those firms that have already registered their drugs.

Sergey Tsyb also noted that the volume of the applications studied suggests that the Russian Federation Ministry of Industry and Trade is able to analyze all production sites.

He also said that to that date, inspections were carried out only on the basis of the statements that relate to the initial drug registration in Russia. It involves those pharmaceutical products which had never been previously registered in the Russian Federation.

Since the beginning of this year 2017, such a condition is relevant for the drugs, which have already been present on the Russian market, including the re-registration of drugs and the confirmation of conformity to the requirements.

He also noted that the Federal Government Institution "State Institute of Medicines and Good Practices" would have the authority to engage in inspections for compliance with the GMP standards.

Experts analyzed previously filed applications for new drugs registrations in Russia, which have accumulated over the past few years. Thanks to this analysis, at the moment it is possible to draw a conclusion, that the Ministry of Industry and Trade and the subordinated FBI "State Institute of Medicines and Good Practices" have a real possibility to comprehensively explore the companies which file applications for a statement of conformity as a part of the drug registration procedure, and will affect only those drugs which are initially registered in the territory of the Russian Federation.

Since January 1, 2014, the production of drugs on the territory of the Russian Federation by pharmaceutical companies, both domestic and foreign, requires full compliance with Russian standards in the framework of Good Manufacturing Practice.

Previously, foreign companies did not need a Russian GMP certificate, but from 2015, a resolution on the procedure for inspecting drug manufacturers has been adopted. The Ministry of Industry and Trade issues these final statements for a period of 3 years subject to the submission of applications.

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