Viktor Nazarenko, EEC Minister in charge of Technical Regulation, spoke on the current aspects of the regulatory framework for regulating the common market of medicinal products in the Eurasian Economic Union, as well as novelties in the procedures for supranational registration of medicines and their access to the Union’s market at the session "Export Potential: the EAEU and the Global Market" of the Russian Pharmaceutical Forum "Drug Safety" as part of SPIEF-2022.
"Life is constantly making adjustments to our work, posing new challenges. We respond to them in a systematic and coordinated manner, while maintaining the priorities of public health, drug safety, and the availability of medicinal products," Viktor Nazarenko stated.
The EEC Minister spoke in detail about many initiatives by the pharmaceutical business that had been taken into account when forming and developing the common Union's market of medicinal products.
The possibility of providing a reduced set of documents of marketing authorization application was introduced in some cases, the possibility of submitting a national GMP certificate for marketing authorization in the Union was extended until December 31, 2024, the GMP rules were updated with the expansion of approaches to production facility validation and certification. Another important trend in the common drug market regulation includes introducing some remote procedures, which has had a positive impact on the overall timing of inspection procedures and laboratory expertise during registration.
In conclusion, the EEC Minister invited drug manufacturers, scientific and research institutions, professional business associations to actively participate on the Commission's platforms in the work of special advisory bodies – working groups intended to develop common approaches to regulating the circulation of medicinal products and medical devices, as well as to participate in procedures of public and social discussion of the Commission's draft acts published on the Legal Portal.