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Russian GMP-Inspectorate. Summary of “Pharma-2020”

On November 10, during plenary session “Results of the governmental program implementation “Development of pharmaceutical and medical industry”: together with the common goal” held within the framework of the 22nd International exhibition Pharmtech & ingredients in Crocus Expo, Vladislav Shestakov, Director of the “SID&GP”, stated about the development of the Russian GMP-Inspectorate and the results of its work for 4 years since its establishment.

The major output for 2020 was the transition to alternative inspection methods due to the complex epidemiological situation that has developed since February 2020 worldwide. In order to avoid the risk of medicines shortage on the Russian market, in coordination with the Ministry of Industry and Trade of the Russian Federation and in terms of the amendments to the Russian Government Decree No. 1314, the Russian Inspectorate is authorized to conduct an inspection of foreign medicines manufacturers by remote assessment using modern technologies, including real-time video-conference. More than 150 of such online-inspections have already been conducted in 2020.

As a significant achievement in the development of the Pharminspectorate and implementation of the governmental program “Pharma-2020”, Vladislav Shestakov noted the work carried out on the Russia’s pre-accession application to the Pharmaceutical Inspection Co-operation Scheme (PIC/S). The Director of the “SID&GP” thanked his colleagues involved in the work of preparing the application. At the meantime, active work is underway on forming a package of documents for the PIC/S Checklist, Questionnaire and application for full membership in PIC/S, which is scheduled for submission in the 4th quarter of 2020.

“This is a complex and multi-stage work, which involves representatives of the Ministry of Industry and Trade of Russian Federation, Federal Service for Surveillance in Healthcare and Social Development (Roszdravnadzor), “SID&GP”, “Scientific Centre for Expert Evaluation of Medicinal Products”, – said Shestakov. – Our preliminary application was reviewed and last autumn we received a positive evaluation of our documents. This is another step towards recognition of our Inspectorate’s competence at the world level”.

Separately, the topic of creating a subsidiary company “National Center of Reference Materials” was touched upon. The main direction of its work was the development, manufacturing and supply of state reference materials. During 9 months of the work, “National Center of Reference Materials” was certified and received sets of documents for three state reference materials: Ibuprofen, Fluconazole and Azithromycin. At present, the development of regulatory documents for 17 new titles of State Standard Samples is underway.

“Undoubtedly, the implementation of the Pharma 2020 strategy has led not only to the development of pharmacopoeia, but also of the Pharminspectorate”, summed up Vladislav Shestakov. – The established system has proved to be effective and in line with international standards. And I am sure that my colleagues from the industry will support me, the Russian inspectorate and quality have long been synonymous”.