Twinning Project Digest | May 2026

Throughout May 2026, the EU Twinning Project “Support the Establishment of the State Control Authority for Medicines and Medical Devices in Ukraine” continued to support Ukrainian institutions in advancing reforms aimed at strengthening regulatory governance, transparency, and alignment with European Union standards.

A series of expert meetings brought together representatives of the Ministry of Health of Ukraine, the State Service of Ukraine on Medicines and Drugs Control (SMDC), the State Expert Center (SEC), the Ukrainian Center for Transplant Coordination (UCTC), and experts from Lithuania and Poland to discuss practical approaches to building effective regulatory and oversight systems.

One of the key topics addressed during May was the development of internal governance and integrity mechanisms for the future state control authority. Lithuanian and Polish experts presented their experience in implementing anti-corruption and internal control systems within medicines regulatory authorities. Discussions focused on risk assessment mechanisms, codes of conduct, management of confidential information, whistleblower protection, conflict-of-interest prevention, handling complaints and petitions, anti-mobbing policies, and cooperation with external experts.

Particular attention was devoted to practical tools that help ensure transparency, accountability, and public trust in regulatory institutions. The Ukrainian side received examples of internal procedures and policy instruments currently applied in Lithuania and Poland, which may serve as reference points for future institutional development in Ukraine.

The final session of Activity 2.2 focused on a comprehensive package of recommendations concerning internal policies and integrity safeguards. EU experts shared practical guidance on establishing ethical standards, conflict-of-interest management systems, anti-corruption procedures, public information access policies, whistleblower protection mechanisms, public procurement safeguards, and anti-mobbing frameworks. These recommendations are expected to contribute to the development of a modern and transparent institutional environment within Ukraine’s medicines regulatory system.

In parallel, the project also supported Ukraine’s preparations for implementing Regulation (EU) 2024/1938 on Substances of Human Origin (SoHO). During a dedicated expert meeting, participants discussed a draft roadmap for implementation of the new EU regulatory framework, including legislative adaptation, institutional responsibilities, licensing and accreditation systems, traceability requirements, vigilance mechanisms, and the investigation of serious adverse reactions and incidents.

The discussions highlighted the importance of establishing a clear and operational implementation framework, identifying regulatory gaps, and defining the future competent authority model for the SoHO sector in Ukraine. Lithuanian experts shared practical experience from EU Member States and provided recommendations on implementation sequencing, sectoral mapping, and institutional coordination.

Together, these activities demonstrate the Twinning Project’s ongoing support for Ukraine’s efforts to strengthen its healthcare regulatory system in line with European standards. By combining legislative approximation with practical institutional development, the project contributes to building transparent, accountable, and effective regulatory structures capable of protecting public health and supporting Ukraine’s European integration process.