The Director of FSI «SID & GP» of the Ministry of Industry and Trade of Russia Mr. Vladislav Shestakov took part in the XI Eurasian Economic Forum
On 26 October, the Director of the Federal State-funded Institution “State Institute of Drugs and Good Practices” Mr. Vladislav Shestakov took part in the XI Eurasian Economic Forum, the main theme of which was outlined as “Economy of Trust and Diplomacy of Business from the Atlantic to the Pacific”. Within the Forum, the most topical issues of cooperation of business communities from the Big Eurasia countries were discussed, including energy, finance, transport, infrastructure projects, new technologies, agriculture, and the pharmaceutical industry.
The pharmaceutical market of the EAEU countries is a rapidly-growing one, which is due to a high demand in innovative and effective drugs and medical solutions. The governmental measures aimed at development of the pharmaceutical industry within the EAEU member countries, healthcare system overhaul towards accessibility of modern medical technologies and drugs – all these allows for the dynamic growth of the pharmaceutical market. The growth of the pharmaceutical industry is also stimulated by recent implementation of numerous programs in the EAEU countries. In Russia, for instance, the “Pharma-2020” program promoted localization of manufacture within the RF territory. The added incentive for development of the regional pharmaceutical market and its national segments is creation of the common market of drugs of the EAEU, harmonization and alignment of legal requirements towards drugs circulation in the EAEU member states.
The Director of FSI “SID & GP” Mr. Vladislav Shestakov gave a report within the session on the topic “EAEU Pharmaceutical Market: Trends, Opportunities, Perspectives”. In his speech, Mr. Vladislav Shestakov covered the issues of development of drugs circulation regulation in the EAEU, outlined new trends and cooperation frameworks for all market players, and talked about integration into the global regulatory environment. Accession to international associations will allow the joint work by inspectorates from different countries on further improvement of good practices, provide for the platform of active experience sharing and training of inspectors, and enhance mutual recognition of the results of inspections on a global level.
“The EAEU member countries are on different steps of PIC/S accession. Currently, as requested by the Ministry of Industry and Trade of the Russian Federation, we are actively engaged in preparation of the documents for forming the inter-departmental working group with members from the Ministry of Industry and Trade, the Ministry of Healthcare, the Federal Service for Surveillance in Healthcare and the State Institute of Drugs and Good Practices” — said the Director of FSI “SID & GP” Mr. Vladislav Shestakov. “It is necessary to implement one of the key PIC/S requirements, which is that the country should be represented by one coordinating authority.”
Within its international activity, the FSI “SID & GP” is actively cooperating not only with the colleagues from the EAEU member countries, but also with other foreign states. The State Institute of Drugs and Good Practices is now negotiating establishment of the GMP Inspectorates Council with the BRICS member countries. This imitative was put forward by the Institute in 2015. Then, the drafts of the Regulation on the Council, its structure, and the BRICS Cooperation Agreement were prepared. At the III GMP Conference held in August 2018, the member countries supported the imitative on establishment of the GMP Inspectorates Council.
- What is in the Programme of V GMP-conference?
- The rules of organizing and conducting inspections of drug manufacturers for the compliance with GMP requirements have been changed
- FSI “SID & GP” of the Ministry of Industry and Trade of the Russian Federation and company Sandoz held the first online forum on biotechnologies
- 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