Analysis of the provisions of national and EAEU legislation regulating pharmaceuticals before and after 1 January 2026

Abstract

Scientific relevance. The gradual transition to the common pharmaceutical market 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 harmonise it with EAEU legislation. However, Russian national 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 analyse the risks of conflicts of laws between these legal systems.Discussion. Analysing 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 pharmacopoeial requirements, and the designation of orphan medicines. The authors examine the relationships between authorisation 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 authorisation 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 authorisation should consider the partial continuation of national regulation after 2026 when developing their regulatory affairs strategies.