Collaboration between Ministry of Health of Ukraine and EDQM on the implementation of new EU regulations in the field of substances of human origin

The Ministry of Health of Ukraine held a meeting with representatives of the European Directorate for the Quality of Medicines and HealthCare (EDQM) of the Council of Europe. The meeting was devoted to discussing prospects for cooperation in the field of substances of human origin (SoHO) and supporting Ukraine in implementing the new EU Regulation on SoHO, which will come into force in 2027. The meeting was chaired by Maryna Slobodnichenko, Deputy Minister of Health of Ukraine for European Integration.

What is the EDQM and what are its competences?

The EDQM is an institution of the Council of Europe, founded in 1964, which brings together 39 member states and the European Union, as well as observer countries. The Directorate develops and implements European standards of quality and safety in the field of medicines, pharmaceutical care, substances of human origin, and consumer health.

In the field of SoHO, the EDQM:

• develops technical and ethical standards;
• coordinates intergovernmental committees on blood, tissues, and cells;
• monitors practices and data;
• supports states in capacity building and implementation of EU and Council of Europe standards.

Areas of cooperation between the Ministry of Health of Ukraine and the EDQM

During the meeting, the parties focused on the following key areas of cooperation:

• strengthening the institutional capacity of the Ukrainian Pharmaceutical Agency
• (UPA) as the future competent authority in the field of SoHO and blood;
• building the capacity of SoHO entities — institutions working with blood, tissues, and cells;
• identifying and mapping SoHO entities in Ukraine;
• methodological and expert support for the implementation of new regulations at the practical level;
• training specialists, developing laboratory control and quality systems.

Particular attention was paid to the formation of a joint plan for further cooperation between the Ministry of Health of Ukraine and the EDQM.

“The information we are discussing today fully meets our needs. We are launching a new national control authority (hereinafter referred to as the NCA), which will become competent in the field of SoHO and blood. The NCA will start operating on January 1, 2027. Therefore, we are strengthening institutional and laboratorial capacity, as well as building strong human resources. Harmonization of legislation with EU law is critically important, but it is equally important for Ukraine to understand how it works in practice," said Maryna Slobodnichenko.

Key challenges and requests of Ukraine

The Ukrainian side outlined a number of challenges that the state is currently working on:

• training experts for the new regulatory body, whose functions will combine regulatory and supervisory roles;
• developing a clear understanding of how SoHO entities operate and who exactly belongs to them;
• strengthening laboratory control and professional expertise;
• obtaining methodological assistance to assess the practical implementation of EU standards “on the ground.”

Forthcoming steps

The parties agreed to:

• develop a roadmap for cooperation between the Ministry of Health of Ukraine and the EDQM;
• continue the dialogue in the format of technical and expert meetings;
• consider opportunities for more active involvement of Ukrainian specialists in European professional networks.

Separately, Ukraine expressed its readiness to share its unique experience in ensuring the blood supply system in conditions of martial law, which is already being used by international partners, in particular within the framework of cooperation with NATO.

“Holding more specialized technical meetings to exchange experience is a good idea. All this can be consolidated into a joint cooperation plan. This approach is the right way forward, and it is important to combine Ukraine's experience with that of EU member states,” said EDQM Director Petra Doerr.

“The time has come to open the door to more systematic cooperation. We can learn a lot from each other. Involving Ukrainian experts in supervisory and expert structures is a promising direction. The next meeting in Strasbourg in April could be a good opportunity to present Ukraine's positions, provide recommendations, and establish professional networking," added Marta Lopez, head of the SoHO research program.

The Ministry of Health would like to thank all colleagues who participated in the meeting for their joint work, professional contribution, and involvement in the development of cooperation in the field of SoHO, and we also express our sincere gratitude to the Permanent Representation of Ukraine to the Council of Europe and the Council of Europe as a whole for their support, partnership, and promotion of the development of this area.