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New regulations for the inspection of pharmaceutical manufacturers

New regulations for the inspection of pharmaceutical manufacturers

The Ministry of Industry and Trade is preparing a regulation for inspecting drug manufacturers. The production facilities will be tested for compliance with the international GMP (Good Manufacturing Practice) standard of the version adopted in the EAEU. The project has already been published on the official resource of the Government. The discussion is open to all participants in the pharmaceutical industry until August 14, 2020. The regulation is expected to come into force in September and is intended to reconcile the requirements of the EAEU GMP standard with Russian legislation on the circulation of medicines. The final proposal was the regulation of inspection in accordance with No. 5-FZ “On the ratification of the Agreement on uniform principles and rules for the circulation of medicines within the EAEU.” In addition, the purpose of the new regulation will be to simplify procedures for accessing the EAEU market: a minimum administrative barrier with a high qualification of production quality. In the future, it is planned to bring the Russian pharmaceutical industry into compliance with related international

GLP and GCP standards (standards for laboratory and clinical activities) and include verification of this compliance in the registration procedure for medicinal products. Naturally, all drugs and pharmaceutical substances registered for the EAEU market will be consolidated into a separate Unified Register and included in a single information system.

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