This was stated by Valentin Tataritsky, Minister in charge of Technical Regulation of the Eurasian Economic Commission, at the strategic session “Integration processes for establishing the EAEU common market of medicines” as part of the scientific-practical conference “Regulatory Practice and Registration of Medicines – RegLek 2024”, held on May 21-23 in Moscow.
The session was devoted to the results of work to ensure the functioning of the Union's common market of medicines and discussion of proposals to improve the Commission's acts shortly before the end of the transition period on December 31, 2025, according to which all medicines circulating in the EAEU market should be harmonized with the Eurasian single regulatory framework.
The event was opened with a welcoming speech by Mikhail Murashko, Minister of Health of the Russian Federation. The session was attended by Deputy Ministers of Health of the EAEU States and representatives of the pharmaceutical business. They presented their experience in the common market of medicines and shared their vision of its development prospects.
According to Valentin Tataritsky, more than 15,000 applications for registration of medicines under the Union's rules have been submitted by March of this year, including more than 6,500 applications under the harmonization procedure. About 5,700 marketing authorizations have been issued. All the EAEU States joined the work. Russia accounts for most of this work, but this year the number of applications from other Union countries for registration of medicinal products and harmonization of their marketing authorization applications has increased significantly.
The EEC Minister touched upon the main stages of evolution of the Marketing Authorization Rules in 2016-2024. In particular, they were supplemented with provisions on the registration of pandemic and pre-pandemic vaccines, defined terms for the sale of medicine residues after their compliance with the Union's requirements, simplified a number of procedures, including the procedures for harmonizing the marketing authorization applications, and introduced the possibility of “remote” testing in the manufacturer's laboratory, which made it possible to overcome logistical COVID restrictions. The list of registration procedures was also supplemented with procedures for simplified and accelerated access to the market for breakthrough and high-performance medicinal products. In 2023, the Marketing Authorization Rules were updated with sections on high-technology medicinal products, the possibility to submit a marketing authorization application without a GMP certificate with inspection during registration or in the post-registration period was extended until December 31, 2024, and the number of documents to be submitted in marketing authorization applications for previously registered medicinal products was significantly reduced.
In 2024, the procedure for making amendments to the marketing authorization application has already been updated, and by the end of the year it is planned to make further clarifications in terms of requirements for products placed in the packaging of a medicinal product and provisions for determining the confidentiality of expert report data.
Valentin Tataritsky emphasized that today the EAEU system of GxP practices, which constitute the life cycle of any medicine, and inspection procedures to confirm compliance with these practices are developing in a rather dynamic way. In 2018, in addition to the five basic good practices (GLP, GCP, GMP, GDP, GVP), the Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin was adopted, and in April 2024, the Pharmaceutical Inspection Regulations were supplemented with an inspection procedure for pharmacovigilance systems.
The EEC Minister noted the evolution of pharmacopoeial cooperation between the EAEU countries, which is of particular importance in terms of its scientific and practical potential. At the meeting of the Commission's Board in June-July 2024, it is planned to adopt the third part of the first volume of the Union Pharmacopoeia devoted to the quality analysis of radiopharmaceutical medicinal products and biological (biotechnological) pharmaceuticals.
The conference thematic sections included reports from representatives of the EAEU Member States' authorized bodies and organizations on developing medicines circulation and medicine provision, control and supervision activities in this field, and bringing the legislation in compliance with the EEC acts and the practice of their application in the Union countries.
In their reports, employees of the EEC Technical Regulation and Accreditation Department informed the conference attendees about special aspects of the adopted and planned changes in registration procedures, as well as development of the GxP system and research.
