Pharmaceutical Sector Overview for Q4 2025

Key legislative changes in pharmaceuticals and healthcare

Pharmaceutical regulation continues to evolve actively: the rules for the registration of medicinal products and medical devices are being updated; requirements for clinical trials, pharmaceutical development, inspections, pricing and advertising are being adjusted; and approaches to public procurement and good practices are being clarified.

A substantial part of the changes is linked to the development of regulation within the EAEU framework and to the extension or revision of transitional periods.

This overview has been prepared in order to present, in a structured and clear manner, the key regulatory developments relevant to manufacturers, marketing authorisation holders, contract organisations, participants in public procurement and other stakeholders in the pharmaceutical market.

The material is designed for practical use and makes it possible to assess which changes have already entered into force, which are at the implementation stage, and what should be taken into account in the near term.

Within the overview you will find:

  • changes to the procedure for the registration of medicinal products and medical devices, including the transition to the EAEU rules;

  • new and updated requirements for pharmaceutical development, clinical trials and inspection activities;

  • adjustments to the regulation of pricing, advertising and good practices;

  • developments affecting public procurement, the attestation of qualified persons and the maintenance of registers;

  • separate sections on the digitalisation of healthcare, assisted reproductive technologies, and the circulation of veterinary medicinal products.

 

Get the overview file

 

This overview, prepared by REVERA Law Group, will be useful both for quick orientation in the current regulatory agenda and for shaping further regulatory and business decisions in light of the applicable requirements.

Authors: Sergey Suschenya, Iryna Navitskaya, Denis Valukevich.

 

We regularly collect and publish all key changes and events in pharmaceuticals and Life Sciences: regulatory updates, practical case analyses, guides and analytical materials. All the latest information is available on our LifeScience Telegram channel.

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