International cooperation discussed at the Drug Safety Forum
Vladislav Shestakov, Director of the FSI “State Institute of Drugs and Good Practices”, took part in the session on Drug Safety: International Cooperation and Search for Joint Solutions at the Russian Pharmaceutical Forum held as part of the SPIEF 2023 in St. Petersburg.
In his speech, he emphasized the need to find joint solutions to provide human beings with quality, effective, and safe medicines, “At the same time, GMP experts still need an independent international platform for professional communication and experience exchange. The creation of the Global Association of Pharmaceutical Inspectorates is aimed at leveling the situation that emerged as drug regulatory affairs experts became constrained from their interaction with the global professional community. The Association may also facilitate the export potential development of the GAPI member states.”
“Creating such a new alliance should be another starting point in ensuring drug safety. 18 countries have already expressed their readiness to join the GAPI working group”, Vladislav Shestakov said.
Speaking about ensuring the country’s drug safety, Vladislav Shestakov noted that it would impossible without improving the availability of medicines, while mitigation of regulatory barriers to drug registration and the accelerated introduction of new drugs into the market are among the effective mechanisms for improving drug safety.
Mutual recognition of GMP certificates issued by different countries can contribute to this. Bilateral intergovernmental agreements will facilitate access to the market for medicines from friendly nations, which, in turn, would facilitate both importing and exporting health products.
“Russia now has a very good export potential. According to the Federal Customs Service data, Russian medicines are supplied to 150 countries around the world, and both the volume of exports and the geography of presence are growing annually. Vaccines are the leader among all pharmacologic classes, but insulins, high-quality generics and innovative biotechnology medicines produced by the domestic pharmaceutical industry leaders are also in great demand abroad,” Vladislav Shestakov concluded.
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