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The first results of the interaction of the GMP inspectorates of the EAEU member countries

Not only the pharmaceutical companies of the EAEU member countries are striving to obtain the GMP certificate of the EAEU - foreign pharmaceutical manufacturers are beginning to join the process. Vladislav Shestakov, director of the FBU GILS and NP, told about this at the RegLek-EAEU conference.

Today at the Holliday Inn, regulators of the EAEU member countries summed up the interim results of preparations for the single EAEU pharmaceutical market and discussed the first results of the interaction of pharmaceutical GMP inspectorates. A number of EAEU member countries have almost passed on supranational standards. For example, the Ministry of Health of Kazakhstan issued a registration certificate "WiiV Healthcare" (United Kingdom) for a drug, in the registration documents of which GMP-certificate issued by the Russian inspection was filed. Currently, 25 applications under registration procedures are accepted for consideration in the Republic of Kazakhstan. 1 application for registration and inspection of medicines in accordance with the rules of the EAEU was accepted for consideration in the Republic of Belarus. 18 of them are applications for pharmaceutical inspections. Moreover, the Ministry of Health of this republic, following the results of the inspection for compliance with the requirements of the rules of good manufacturing practice of the EAEU, issued a GMP certificate to the Eastern European manufacturer Bosnalek. Thus, there is a tendency to obtain the EAEU GMP certificate by all drug manufacturers.

Among the most successful cooperation points of the inspectorates of the EAEU member countries that are of interest to their foreign colleagues, Vladislav Shestakov noted joint inspections:

“The issue of trust today is relevant not only for regulators of the EAEU, but also for Latin American countries. Colleagues interested in our experience of the EAEU. And within the framework of our two-week meetings, the proposal arose to hold a scientific-practical conference between the countries of Latin America and the EAEU.”

As the Director of FBU GILS and NP noted, today 4 joint inspections have been carried out (and they were carried out not only in the EAEU, but also in Hungary and Turkey) and the criteria for including inspectors in the joint inspection team are being worked out.

“Just a couple of months ago, in Armenia, an enterprise for the production of infusion, injection and ophthalmic drugs at a planned inspection in accordance with the Inspection Plan for 2019, inspectors from Belarus, the Republic of Kyrgyzstan and the Russian Federation attended observer status,” Vladislav Shestakov said. - The inspectors worked out the interaction procedures in terms of general approaches to the inspection procedure, on organization and planning, directly on the inspection procedure and evaluation of inspection results, that is, approaches to the classification of nonconformities. In this regard, third-level documents are very useful in accordance with the approved list. For example, in the event of a controversial issue related to the water treatment system, inspectors turned to the management in these documents, which made it possible to remove the controversial issue. ”

The deputy head of the Russian GMP Inspectorate, Vladislav Shestakov, is convinced that such joint inspections raise the level of competence of all countries, they allow us to develop uniform standards in conducting inspections and classifying inconsistencies themselves: “The most important thing is the level of professional trust in each other.”

Also at the conference it was announced that the FBU GILS and NP together with the Cuban regulator CECMED will conduct in September 2019 a joint inspection of the GEROPHARM production site. (Recall that following the results of the business mission to Cuba, Geropharm submitted documents for registration of 2 insulins in this region.) The second joint inspection with CECMED is planned for the MECHNIKOV plant in Nicaragua.

According to the press service "GILS and NP"

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