The PIC/S Committee convened in Chicago (USA), on September 24-25, 2018. Tatyana Nikolko, Deputy Head of the Administration for Pharmaceutical Products Inspection and Evaluation of the State Institute of Drugs and Good Practices of the Russian Ministry of Industry and Trade took the floor with a presentation on the Russian GMP Inspectorate and the EAEC regulatory documents.
The speaker focused on the application of GMP rules during inspections. Tatyana spoke of the requirements for registration and inspection of drugs for human use in Russia. She paid special attention to the activities of the Russian GMP Inspectorate: 80 inspectors, their qualification requirements, and inspections dynamics. She noted that ‘since 2016, foreign manufacturers submitted 1843 applications to the Russia Ministry of Industry and Trade, 1660 of them were referred to the State Institute of Drugs and Good Practices, followed by 1166 inspections and 862 GMP certificates issued.’
A significant part of her report was devoted to the approaches and rules for inspections as governed by the provisions, regulatory documents and GMP rules of the EAEU, in force since May 2017.
“The rules establish that the EAEU GMP certificate becomes an integral part of the registration dossier. Presently, great efforts are made to harmonize and finalize the documents in accordance with the EAEU standards regulating GMP inspections. By the end of 2019, we plan to approve 64 documents: 20 of them will govern production and quality, 9 will cover requirements for alternative medicines, 21 pertain to preclinical and clinical trials, and 14 general documents. The EAEU member states are very resolute to harmonize their inspection approaches, unify inspection rules, assessment of the inspection results, and staff training,” commented Tatyana Nikolko.
In August 2017, the Department of Pharmaceutical and Medical Industry Development of the Russian Ministry of Industry and Trade, together with the State Institute of Industry and Trade, filed a preliminary application for membership in the PIC/S. The Russian Pharmaceutical Inspectorate is working on the establishment of an Interdepartmental Working Group, which will include representatives of the authorized federal executive agencies, i.e. Ministry of Industry and Trade of the Russian Federation in cooperation with the State Institute of Drugs and Good Practices; Ministry of Health of the Russian Federation and the Federal Service for Surveillance in Healthcare.