In 2025, the healthcare industry faced not only massive regulatory changes, but also the development of several important trends in court and administrative practice.
The main regulatory topics were the expiration of the deadline for aligning local registration dossiers with the Eurasian Economic Union (the EEU) requirements and the legislative amendments to preserve the local dossiers which had not been updated by the deadline (31 December 2025).
The reform of the national regime in public procurement also had a significant impact on the industry. This reform was the result of the government’s policy of technological independence that includes, inter alia, supporting Russian companies from the life sciences industry and encouraging local production of medical products.
On a separate track, the lawmaker began addressing long-standing industry issues: integration of dietary supplements and unified clinical protocols into medical practice, restructuring payments in clinical trials, etc.
The main regulatory topics were the expiration of the deadline for aligning local registration dossiers with the Eurasian Economic Union (the EEU) requirements and the legislative amendments to preserve the local dossiers which had not been updated by the deadline (31 December 2025).
The reform of the national regime in public procurement also had a significant impact on the industry. This reform was the result of the government’s policy of technological independence that includes, inter alia, supporting Russian companies from the life sciences industry and encouraging local production of medical products.
On a separate track, the lawmaker began addressing long-standing industry issues: integration of dietary supplements and unified clinical protocols into medical practice, restructuring payments in clinical trials, etc.
Court practice, in turn, tried to balance the interests of innovative and generic companies, alternating between defending originators and supporting generic manufacturers.
Sanctions and counter-sanctions issues also remained relevant. Both the European Union (the EU) and Russia introduced various restrictive measures in the past year. However, compared to 2024 and 2023, their impact on the industry was quite limited.
To help you navigate your journey through the changing regulatory environment, we have prepared this annual review of the key legal developments in the life sciences industry. We hope you will find this review helpful.
To help you navigate your journey through the changing regulatory environment, we have prepared this annual review of the key legal developments in the life sciences industry. We hope you will find this review helpful.
Authors
- Vsevolod Tyupa, Partner, Head of Life Sciences & Healthcare, vsevolod.tyupa@sl-legal.ru
- Ivan Zaraiskiy, Senior Associate, ivan.zaraiskiy@sl-legal.ru
- Violetta Gavrilova, Paralegal, violetta.gavrilova@sl-legal.ru
- Ekaterina Kharina, Paralegal, ekaterina.kharina@sl-legal.ru