Transition to Single EAEU Market will Save Pharmaceutical Manufacturers from Double Inspections

03 October 2019

GMP News

The transition to a single market will save pharmaceutical manufacturers from double inspections and will help optimize the actions of national GMP inspectors – such an opinion was expressed by the panel discussion “Confirmation of GMP compliance as part of the transition to a single market” (Svetlogorsk, All-Russian GMP conference).

At the event moderated by Vladislav Shestakov, Director of the Federal State Budgetary Institution “GILS and NP” of the Ministry of Industry and Trade of Russia, the goals of the transition to a single space and those tasks that require solutions in the field of regulation, inspection and production of drugs were discussed.

Representatives of Armenia, Belarus, Kyrgyzstan and Kazakhstan spoke about the transitional period for the pharmaceutical industry in different countries and the current status of national legislations of the EAEU member states. Currently, all these countries are working on the harmonization of norms and requirements, in accordance with plans for the Eurasian integration of pharmaceutical legislation and the formation of a single market. For example, in Belarus, the final transition to certification according to the rules of the EAEU is expected in 2025, and in Kyrgyzstan – in 2026.

Vladimir Shipkov, Executive Director of the Association of International Pharmaceutical Manufacturers (AIPM), expressed the view that this work could be completed earlier. This thesis sparked a lively discussion.

In particular, Madina Sottaeva, Head of the Department for International Cooperation of Pharmaceutical Inspectorates of the Inspection and Expertise Office of the Federal State Institution “GILS and NP” of the Ministry of Industry and Trade of Russia, positively evaluated the steps that are being taken by all parties towards the transition to GMP certification under the EAEU rules. The speakers came to the conclusion that a single system, as a whole organism, leaves much to be desired and there is a lot of room for improvement in this area. The discussion also touched on the issue of authorized persons as key personnel of GMP. In a short time, they will have to get the competencies that are necessary in the framework of the transition to the requirements of the EAEU.

Experts saw a certain problem in the abolition of acts and regulations of the USSR in Russia, in connection with which enterprises would have to revise and optimize large volumes of documentation. On the other hand, this will make it possible to create modern transparent requirements that correspond to new realities, including Eurasian integration. In addition, the discussion participants discussed the tasks associated with the formation of a single drug registry.




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