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The experience of the Russian GMP inspectorate is adopted by the Republic of Belarus

For several years, there has been an active formation of a single market for the circulation of medicines in the Eurasian Economic Union, a supranational regulatory framework is being developed, with which the national legislations of the Union member countries are harmonized. GMP inspectorates have been formed in each member state of the EAEU, and the mutual exchange of experience goes hand in hand with the formation of a single market and the development of uniform rules in the field of drug circulation.

The legislation of the Eurasian Economic Union provides for the exchange of experience between the EAEU member states, as well as joint training and inspection. Since 2016, joint inspections and training of pharmaceutical inspectorates of all five states have been carried out. The level of trust for the procedure of mutual recognition of inspection results is formed during such events. During all these years, the formation and simultaneous improvement of the quality system of pharmaceutical inspectorates of each of the Member States of the Union is also underway.

In June 2022, the Ministry of Health of the Republic of Belarus plans to create a quality assurance department, in connection with which colleagues from the pharmaceutical inspectorate of the Ministry of Health of the Republic, within the framework of the Cooperation Agreement, turned to the FSI “SID and GP” of the Ministry of Industry and Trade of Russia with a request for methodological assistance. The Institute provides support to all inspectorates of the EAEU Member States, in particular, the inspectorate of the Republic of Belarus.

The successful experience of the Russian GMP inspectorate in conducting inspections using remote interaction tools was adopted by the EAEU member states: the Russian GMP inspectorate provided Belarusian colleagues with a standard on the procedure for conducting remote inspections.

Elena Lavnik, Head of the Pharmaceutical Inspection Department of the Ministry of Health of the Republic of Belarus, Head of the Pharmaceutical Inspectorate of the Republic of Belarus, notes:

We have been cooperating with FSI SID&GP for more than a year. And we are grateful to our colleagues from the Russian GMP inspectorate for an open dialogue on the way of harmonizing approaches to the inspection of pharmaceutical production for compliance with the requirements of good manufacturing practice. As part of our Cooperation Agreement, we conduct joint training inspections, exchange practical experience, and take an active part in the development of training modules for the Eurasian Academy of Good Practices. I am sure that all this contributes to the strengthening of relations between our countries and contributes to the expansion of cooperation in the formation of a single market for medicines.

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