Interaction points were discussed by SID & GP with EDQM

A meeting with the Deputy Head of the Russian State GMP Inspectorate, the Director of FSI «SID & GP» Mr. Vladislav Shestakov was organized at the headquarters of the European Directorate for the Quality of Medicines (EDQM) in Strasbourg.

On this day, in Strasbourg (France), a meeting was held between the Head of EDQM Ms. Susanne Keitel and Mr. Vladislav Shestakov, the Director of FSI «SID & GP» authorized to carry-out inspections of foreign drug manufacturers for compliance with Good Manufacturing Practice (GMP). The parties shared the experience in evaluating new applications, revision of CEP certificates, and agreed on future cooperation.

«An opportunity to have a face-to-face encounter at the highest level is indeed a very important step towards reliance and cooperation between the regulatory authorities», convinced Mr. Vladislav Shestakov. «Moreover, one of the global tasks inspectorates of any region are facing today is establishment of the common informational platform for communication. This includes exchange of the data about inspections carried-out, informing about deficiencies found, detection of adulterated products, performance of joint inspections, sharing the best practices and all that will promote universal harmonization of rules and convergence of regulators’ positions and, consequently, improvement of the quality of life. I am confident that mutual trust between regulators will significantly reduce the stress on the business and the industry and will allow focusing on development of innovative and breakthrough drugs», commented the Director of FSI «SID & GP» on the outcomes of the meeting.

Apart from compliance with global GMP and GLP standards, the topic of reference standards was also covered at the meeting. EDQM is the operator managing the common system of reference standards within the European Union. In Russia, the process of establishing the national bank of reference standards has just been launched under the initiative documented in the Order from the First Deputy Minister of Industry and Trade of the Russian Federation, which has resulted from some anti-Russia sanctions. The project has already elicited response from Russian API manufacturers, as the issue of the status of compendial reference standards for medicinal drugs manufactured in Russia and having active ingredients not listed in foreign pharmacopoeias is associated with absence of the procedure for approval of normative documentation for reference standards and their listing in the State Register of Medicines. According to the Deputy Head of the Russian State GMP Inspectorate, the common national bank of reference standards will satisfy the needs of not only Russian manufacturers, but those of EAEU member countries as well. Besides, to implement the project, it is planned to establish a single operator (similar to EDQM), to create a single system for development, manufacture, attestation and monitoring of reference standards.

The meeting held between the European Directorate for the Quality of Medicines and SID & GP is the result of the methodical effort by the Russian team towards harmonization of national and supra-national standards of drug manufacture and quality control, expansion of cooperation with other inspectorates, top global unions and associations: EMA, WHO, PIC/S, ISPE, etc. Only in 2018, working meetings were held with regulators from Great Britain, Italy, Japan, Belgium, Singapore, Saudi Arabia, China and Nicaragua. Within the framework of integrative economic alliances, FSI «SID & GP» suggested establishment of the union of GMP inspectorate of BRICS member states. Such an imitative was supported by the pharmaceutical inspectorates of the EC and other countries.