Analysis of the Provisions of National and EAEU Legislation Regulating Pharmaceuticals before and after 1 January 2026

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Scientific Centre for Expert Evaluation of Medicinal Products, 8/2 Petrovsky Blvd, Moscow 127051, Russian Federation

Н Ekaterina M. Rychikhina; richikhina@expmed.ru

Abstract

Scientific relevance. The gradual transition to the common pharmaceutical mar¬ket within the Eurasian Economic Union (EAEU) is expected to be completed by the end of 2025, and a new regulatory framework is currently being developed at both the national and supranational levels. The main changes in Russian national legislation are aimed to harmonize it with EAEU legislation. However, Russian na¬tional legislation will continue regulating a range of issues related to the life cycle of medicines.

Aim. This study aimed to compare the Russian and EAEU legal frameworks regulating medicines before and after January 2026, as well as to analyze the risks of conflicts of laws between these legal systems.

Discussion. Analyzing the causes of potential conflicts of laws between Russian and EAEU legislation, the authors consider solutions for such conflicts outlined in the legal system of the Russian Federation, as well as the applicability of these solutions to specific situations in the national and supranational regulation of medicines. This study analyses the stages in the life cycle of medicines associated with the highest risk of conflicts of laws, including clinical trials, the development of pharmacopoeia requirements, and the designation of orphan medicines. The authors examine the relationships between authorization procedures during the transition period with both legal systems in effect. The analysis highlights the issues that will continue to be regulated under Russian national legislation after the completion of the transition period, such as the inclusion of active substances in the Russian State Register of Medicines, the authorization of medicines during armed conflicts or other emergencies, and the interchangeability of medicines. Given the evolving requirements of the regulatory environment, this study provides suggestions for enhancing the regulatory framework and recommendations for applicants.

Conclusions. After the complete transition to the common market in the EAEU, certain requirements of Russian Federal Law No. 61-FZ “On Circulation of Medicines” of 12 April 2010 will remain effective in the Russian Federation. Therefore, during the transition period, applicants for authorization should consider the partial continuation of national regulation after 2026 when developing their regulatory affairs strategies.

For citation: Zaremba A.G., Rychikhina E.M. Analysis of the provisions of national and EAEU legislation regulating pharmaceuticals before and after 1 January 2026. Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. Regulatory Research and Medicine Evaluation. 2023;13(4):586-600. https://doi.org/10.30895/1991-2919- 2023-13-4-586-600

ABOUT THE AUTHORS

Aleksey G. Zaremba

ORCID: https://orcid.org/0009-0002-9922-7477 zaremba@expmed.ru

Ekaterina M. Rychikhina, Cand. Sci. (Biol.)

ORCID: https://orcid.org/0000-0001-8728-2538 richikhina@expmed.ru

Received 22 September 2023

Revised 2 November 2023

Accepted 23 November 2023