The expansion of cooperation in the pharmaceutical and medical industries discussed at the INNOPROM. Central Asia international exhibition

A wide range of participants in the session proves the interest in expanding mutually beneficial cooperation. The session was attended by officials of the Ministry of Industry and Trade of the Russian Federation, the FSI “SID & GP”, subordinate agencies of the Ministry of Health of the Russian Federation and the Ministry of Health of the Republic of Uzbekistan, the State Medical Insurance Fund of the Republic of Uzbekistan, and heads of Russian pharmaceutical companies.

Dmitry Galkin, Director of the Department for the Pharmaceutical and Medical Industry Development of the Ministry of Industry and Trade of the Russian Federation, spoke about the implementation of the Roadmap on the assessment and harmonization of regulation in the field of Good Manufacturing Practice in the Russian Federation and the Republic of Uzbekistan, signed in 2023. The activities planned within the framework of the Roadmap for 2023 had been completed, however, due to the need to make certain changes to the legislation of the Republic of Uzbekistan, the work would continue in 2024, Dmitry Galkin said.

During the discussion, Petr Rodionov, CEO of GEROPHARM, shared his experience of undergoing an inspection for compliance with the requirements of GMP rules, conducted by the regulatory authority of the Russian Federation, which was also attended by representatives of the regulatory authority of the Republic of Uzbekistan as observers. “We strongly support such an experience exchange and synchronization, convergence of approaches to inspection. For the development of the industry, a strong regulatory authority is needed in terms of developing uniform rules for GMP standards, which should be interpreted and applied equally strictly to both beginners and large manufacturers, and for both domestic and foreign companies,” Petr Rodionov indicated.

Madina Sottaeva, Head of the Pharmaceutical Manufacturing Inspection Department of the FSI “SID & GP” of the Ministry of Industry and Trade of the Russian Federation, spoke about the assessment of approaches to inspection. With similar approaches to inspection, the differences are there in the GMP rules themselves, i.e. the EAEU GMP Rules are applied in the Russian Federation, and they are equivalent to the rules of the Pharmaceutical Inspection Cooperation Scheme (PIC/S), so, harmonization of rules and other normative legal acts is needed for the final assessment, Madina Sottaeva underlined.

Aziz Dusmatov, Director of the State Unitary Enterprise “Center for Good Practices” of the Agency for the Development of the Pharmaceutical Industry of the Ministry of Health of the Republic of Uzbekistan, noted that the leadership of the Republic pays great attention to the pharmaceutical industry, the work on the signed Roadmap continues, and recommendations on amendments to regulatory legal acts are to be submitted to the Government of the Republic of Uzbekistan by the end of 2024.