The first outcomes of cooperation between pharmaceutical inspectorates of the EAEU member countries
Not only pharmaceutical companies of the EAEU member countries are reaching after obtaining an EAEU GMP certificate – the process is starting to involve foreign pharmaceutical manufacturers as well. This was brought to light by the Director of SID & GP Mr. Vladislav Shestakov at the «RegLec-EAEU» conference.
This day, in Holiday Inn, regulators of the EAEU member countries summed up the interim results of preparation for the common EAEU’s pharmaceutical market and discussed the first outcomes of cooperation between pharmaceutical inspectorates. Some EAEU member states have already completely switched to supranational standards. For instance, the Ministry of Health of Kazakhstan has issued a Marketing Authorization to ViiV Healthcare (Great Britain) for the drug product the filing of which contained a GMP certificate issued based on the results of the Russian inspection. Currently, 25 registration files have been accepted for consideration in the Republic of Kazakhstan. One application for drug registration and inspection under the EAEU regulations has been accepted for consideration in the Republic of Belarus. Eighteen out of them are applications for carrying-out pharmaceutical inspections. Moreover, this Republic’s Ministry of Health has issued a GMP certificate to an Eastern-European manufacturer Bosnalijek based on the results of the inspection for compliance with the requirements of Good Manufacturing Practice. Consequently, the trend of obtaining an EAEU GMP certificate by all drug manufacturers is obvious.
Among the most successful examples of cooperation between inspectorates of the EAEU member states which are of interest for foreign colleagues, joint inspections were emphasized by Mr. Vladislav Shestakov: «The topic of reliance is hot not only for the EAEU’s regulators, but also for Latin American countries. The colleagues got interested in our experience in the EAEU. And within our two-week’s discussions, we initiated a proposal of holding a scientific and practical conference between the countries of Latin America and the EAEU. According to the Director of SID & GP, as of today, 4 joint inspections have been carried out (wherein not only in the EAEU, but also in Hungary, Turkey) and the criteria for including inspectors into joint inspection teams are being worked through. “Just a couple of months ago, in Armenia, at the facility manufacturing infusions, injections and ophthalmic preparations, a scheduled inspection under the Inspection Plan for 2019 included observers from the Republic of Belarus, the Republic of Kyrgyzstan and the Russian Federation,» Mr. Vladislav Shestakov said. «The inspectors were mastering the procedures of cooperation in part of common approaches to the inspection procedure, organization and planning, carrying-out of an inspection and assessment of the results of an inspection i.e. approaches to classification of deficiencies. Here, the third-level documents according to the approved list are of great help. For example, in case of a debatable issue related to the water treatment system, the inspectors turned to the guideline provided for in those documents, and that allowed for resolving the issue.»
The Deputy Head of the Russian GMP inspectorate Mr. Vladislav Shestakov is confident that such joint inspections increase the level of competence of all countries and allow for elaboration of common standards for carrying-out the inspections and classifying the deficiencies. «Most important is that we establish professional reliance towards each other.»
Besides, it was presented at the conference that SID & GP would carry out a joint inspection of the Geropharm manufacturing site in September, 2019 together with the Cuban regulator CECMED. (As a reminder, based on the outcomes of the business mission to Cuba, Geropharm filed an application for registration of 2 insulins in that region). The second joint inspection with CECMED is planned to be carried out at the MECHNIKOV site in Nicaragua.
- The SID&GP under the auspices of the Ministry of Industry and Trade of the Russian Federation conducted the first online inspection of Roche’s manufacturing site
- Rules for organizing and conducting inspection of pharmaceutical manufacturers for compliance with GMP requirements have been changed
- Pharma is under control
- PIC/S Meetings in Toyama (Japan)
- Russia will be able to join PIC/S and break into new pharmaceutical markets