Russian Pharma Supports Unified EAEU GMP Inspectorate

11 November 2019

GMP News

Association of Pharmaceutical Manufacturers of the Eurasian Economic Union with the support of the Ministry of Industry and Trade of Russia, the Eurasian Economic Commission held a specialized conference on the development of the pharmaceutical market of the Union.

The topic of the event was the issue of trust between the regulators of the 5 states forming the EAEU. This topic was continued at the session “GMP Standards as the Main Guarantee for the Provision of Quality Medicines to the Population of the EAEU Member Countries”.

The deputy head of the Russian state GMP-inspectorate, director of the State Institute of Drugs and Good Practices Vladislav Shestakov, opening the session, noted that a DIA conference was held a week ago in Moscow, where for the first time the urgent need for a single structure that would support, develop and accompany the regional integration process was voiced in terms of creating a single market.

In development of the above, Dmitry Chagin, Chairman of the Board of the Association of Pharmaceutical Manufacturers of the EAEU, emphasized that currently, in the framework of bringing the national regulatory rules to supranational rules of the EAEU, there is a difference in approaches and methods for assessing manufacturers for compliance with GMP requirements (for example, the cost of an inspection in the member countries of the Union, the regulatory deadlines for conducting an inspection, qualification requirements and certification of inspectors, lack of experience with specific types of drugs), as well as country profiles (the inspectorate of the Russian Federation possesses today 90 inspectors; over the course of three years, about 1000 inspections of Russian and 1800 inspections of foreign manufacturers have been carried out).

The head of the Association of Pharmaceutical Manufacturers of the EAEU emphasized that not only the proper rules for the production of medicines should be uniformed, but also the procedure for conducting inspections in terms of the timing of individual stages of inspection, which are referred to the level of legislation of the Member States of the Union, and that, probably, based on this the approach and experience of the European Union with regard to the regulation of the pharmaceutical market, these procedures are ensured through the creation of unified bodies, expert commissions and inspectorate.



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