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Belarus learning from Russian GMP Inspectorate’s experience

Over the last several years, one could observe an active development of the common pharmaceutical market of the Eurasian Economic Union as well as elaboration of a supranational regulatory framework that the EAEU member states’ national laws would be harmonised with.  Each EAEU member state has established GMP inspectorates, with the experience exchange being underway simultaneously with building a common market and making uniform rules for drug circulation.

The EAEU legislation provides for experience exchange among its member states along with having joint training activities and inspections. Joint inspections and training activities for pharmaceutical inspectorates of all the five member states have been taking place since 2016. It is during such events that a confidence level for the mutual recognition of inspection findings is gained. Pharmaceutical quality system of each of the EAEU inspectorate is being developed and concurrently enhanced.

In June 2022, the Ministry of Healthcare of the Republic of Belarus is planning to constitute a division for quality assurance. Thus, the colleagues from the pharmaceutical inspectorate of the Ministry of Healthcare of Belarus approached the FSI “State Institute of Drugs & Good Practices”, Russian Ministry of Industry and Trade, for a methodological assistance, within the framework of the Cooperation Agreement. The Institute extends support to the inspectorates of all the EAEU member states, including the inspectorate of the Republic of Belarus.

A positive experience of Russian GMP Inspectorate in holding remote inspections has been adopted by EAEU member states, and Russian GMP Inspectorate has shared the standard procedure for remote inspections with their Belarusian colleagues.

“We have been sustaining cooperation with the FSI “SID & GP” for a number of years. We are grateful to our colleagues from Russian GMP Inspectorate for an open dialogue on the way to harmonisation of approaches to inspecting pharmaceutical manufacturers for their compliance with the GMP rules”, Yelena Lavnik, Head of the Pharmaceutical Inspection Division of the Ministry of Healthcare of Belarus, Head of the Pharmaceutical Inspectorate of Belarus, says. “Under our Cooperation Agreement, we conduct joint mock inspections, exchange practical experience, and take an active part in devising training modules for the Eurasian Academy of Good Practices. I am sure all this will facilitate strengthening the relations between our countries and contribute to expanding the cooperation in terms of evolving the common pharmaceutical market”.