FSI «SID & GP»
The Ministry of industry and trade of the Russian Federation
+7 (495) 676-43-60 109044, Moscow, Lavrov lane., 6

Russian Federation has submitted an application for the Pharmaceutical Inspection Co-operation Scheme PIC/S accession

On December 18, Russian Federation submitted an application for the Pharmaceutical Inspection Co-operation Scheme PIC/S accession. Russia’s activities on accession to PIC/S have been underway since 2017. A year ago, a pre-accession application to the Scheme was submitted and approved. And at the end of this year, the main application was submitted. Now Russia is waiting for approval of the application for full membership in the Co-operation Scheme.

PIC/S (Pharmaceutical Inspection Co-operation Scheme) is an international organization that unites 54 foreign GMP Inspectorates. The goal of the organization is to develop, implement and maintain harmonized GMP standards and quality systems for pharmaceutical inspections, as well as to strengthen trust and interaction between Inspectorates from different countries.

Several entities of the Russian Federation and their subordinate institutions took part in preparing the joint application: Ministry of Industry and Trade of the Russian Federation, SID&GP, Federal Service for Surveillance in Healthcare (Roszdravnadzor) and Federal State Institution “Scientific Centre for Expert Evaluation of Medicinal Products” of Russian Ministry of Health.

“I am grateful to my colleagues from the Russian Ministry of Industry and Trade, the Russian Ministry of Health and Roszdravnadzor for working together to prepare the documents and application for PIC/S accession,” notes Sergey Tsyb, First Deputy Minister of Industry and Trade of the Russian Federation. – It has been a long, difficult and hard work, which without joint efforts and willingness to cooperate would not have been possible. The very fact of the main application submission is already an indicator of the high level of professionalism of the Russian Inspectorate.”

Accession to the PIC/S would give the Russian GMP Inspectorate the possibility to participate in the work on the advanced inspection-related documents take part in discussions and development of new recommendations on the inspection of drug manufacturers for their conformity with good practices. In addition, PIC/S member list includes representatives of world inspectorates and organization in the field of healthcare, such as the US FDA, the EMA, WHO and others.

A big advantage of the PIC/S membership is the access to informational and educational resources of the PIC/S Inspectorates’ Academy (PIA). The purpose of the Academy – harmonization and standardization of the GMP training at the international level. Such access provides an opportunity for Russian GMP Inspectorates not only to leverage a knowledge database of the recognized world agencies for drug inspection, but als0 act in the capacity of experts and share with accumulated experience.

«Acceding to the PIC/S gives the Russian Inspectorate a recognition of high quality regulatory standards in the field of drugs at the international standard levels of 50 PIC/S member-states. Certainly, such recognition of our inspectors’ high-level expertise – is prestigious and offers us the possibility to have a dialogue with the world’s leading agencies on the same level”. – notes Deputy head of the Russian GMP Inspectorate Vladislav Shestakov.