In fulfillment of the government Strategy for the Development of the Health Care System for the period until 2030, Ukraine is pursuing a European integration vector in the fields of health care and pharmaceuticals.
As part of this course, the Center is consistently working on harmonizing the regulatory system in the sphere of medicinal product circulation with EU legislation, deepening integration into the European regulatory space, and developing bilateral and multilateral cooperation.
The results of this work are signed Memoranda and Agreements, official membership in international organizations and multilateral initiatives, participation of our experts in EU training projects and EMA working groups (European Medicines Agency), and more.
Within just 2023-2025 years, Memoranda of Cooperation were signed with the medicines regulatory agencies of Sweden, Poland, Croatia and Moldova, as well as an Agreement on Authorization and Confidentiality Obligations with the Food and Drug Administration (FDA), USA – one of the most authoritative in the world. The cooperation makes it possible to maintain a constant dialogue with regulators and to integrate the best international practices into the daily work of the Center.
In 2026, we continued our integration into the European and global regulatory space.
Key steps of 2025
- As part of the Ukrainian delegation, we took part in the screening of the compliance of Ukrainian legislation with EU law (Chapter 28 “Consumer and Health Protection”) and received a high assessment of the compliance of the legislation regulating the life cycle of medicinal products with EU legal norms.
- Took part in the 120th meeting of the Heads of Medicines Agencies (HMA) for dialogue, exchange of experience and convergence with European standards in pharmaceutical regulation.
- As part of the Review Mission of European Regulatory Agencies in Kyiv, at the invitation of the MoH, they took part in meetings with regulators of Poland, Croatia, France, Denmark and Sweden. The aim is to adapt Ukrainian legislation to EU standards and to implement the best international practices.
- Participated in the joint meeting of PRAC and CMDh to learn about the current state of the pharmacovigilance and medicinal product safety field in EU countries and the practical aspects of improving regulatory approaches and registration processes.
- Took part in the EMA scientific conference dedicated to the 30th anniversary of the Agency, where the future of healthcare and scientific priorities were discussed.
Further plans
Our course remains unchanged: systematic further development of partnership with EU and global institutions in order to provide the population of Ukraine with effective, high-quality and safe medicinal products.
We are moving toward European integration through real changes, cooperation, and solutions that work for patients.
More details are in separate sections of the “International Activities” heading.
Participation in multilateral coalitions/initiatives
- Participation in multilateral coalitions/initiatives
International technical assistance
For the further development of the pharmaceutical sector, the approximation of national legislation to EU legislation, its implementation and subsequent effective use, the Center draws on all opportunities to enhance the competencies, knowledge and experience of its specialists, in particular international technical assistance from European Union member states and other countries of the world.
Agreements and Memoranda
The State Expert Center of the Ministry of Health of Ukraine has formalized working relations with a number of international organizations/national regulatory authorities (NRAs) by concluding agreements and memoranda. These arrangements enable the parties to exchange information and provide a basis for regulatory cooperation. Particular attention is paid to the exchange of information* on regulatory legal acts and legislation, information on the safety of medicinal products, including adverse reactions, and the results of good clinical practice (GCP) inspections, as well as the exchange of experience and training.
*Exchange of non-public (for internal use) confidential information is carried out only provided that its protection is ensured in accordance with the legislation of the signatory parties and the provisions of the relevant agreements.
The State Expert Center of the Ministry of Health of Ukraine has agreements and memoranda of understanding with international organizations and national regulatory authorities of the following countries:
