Analysis of the Main Changes in Assessment and Approval of Medicines for Human Use in the Eurasian Economic Union
https://doi.org/10.30895/1991-2919-2022-12-2-222-226
Abstract
The article presents a comprehensive analysis of the main changes to the Rules of marketing authorisation and assessment of medicinal products for human use in the Eurasian Economic Union (EAEU). The reflection of regulatory procedures in the legislation is quite a significant systemic feature that makes it possible to establish common requirements for the medicines present in the EAEU and to ensure the possibility of unified regulation of the matter within the national economies of the member states.
About the Authors
О. G. Nefidova
Scientific Centre for Expert Evaluation of Medicinal Products; I.M. Sechenov First Moscow State Medical University (Sechenov University)
Russian Federation
Russian Federation
Olga G. Nefidova
8/2 Petrovsky Blvd, Moscow 127051
8/2 Trubetskaya St., Moscow 119991
D. V. Babaskin
I.M. Sechenov First Moscow State Medical University (Sechenov University)
Russian Federation
Russian Federation
Dmitry V. Babaskin, Dr. Sci. (Med.), Associate Professor
8/2 Trubetskaya St., Moscow 119991
A. D. Sazonov
Ministry of Health of the Russian Federation
Russian Federation
Russian Federation
Aleksey D. Sazonov
3 Rakhmanovsky Ln., GSP-4, Moscow 127994
A. A. Kamaletdinova
Ministry of Health of the Russian Federation
Russian Federation
Russian Federation
Aisylu A. Kamaletdinova
3 Rakhmanovsky Ln., GSP-4, Moscow 127994
References
1. Popov AYu. The main directions of improving the efficiency of regulating the circulation of medical devices within the EAEU. Yuridicheskaya nauka = Legal Science. 2022;1:63–7 (In Russ.)
2. Aristov AV, Aristov YuI, Ganuskus AP. Circulation of unregistered medicines in the Russian Federation: actual problems of social security of certain categories of citizens. Ceteris Paribus = Ceteris Paribus. 2022;3:16–23 (In Russ.)
Supplementary files
Review
For citations:
Nefidova О.G., Babaskin D.V., Sazonov A.D., Kamaletdinova A.A. Analysis of the Main Changes in Assessment and Approval of Medicines for Human Use in the Eurasian Economic Union. Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. Regulatory Research and Medicine Evaluation. 2022;12(2):222-226. (In Russ.) https://doi.org/10.30895/1991-2919-2022-12-2-222-226
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