What will the European medicines regulatory system look like in ten years? How can procedures be simplified, decision-making accelerated and modern technologies used more effectively while maintaining high standards of medicine quality and safety?
These questions were central at the 125th meeting of the Heads of Medicines Agencies (HMA), held on October 5–7, 2026, in Dublin (Ireland).
At the invitation of the Irish regulatory authority, the Health Products Regulatory Authority (HPRA), a delegation of the State Expert Center of the Ministry of Health of Ukraine, headed by Director Edem Adamanov, took part in the event.
HMA brings together the heads of the national medicines agencies of European countries. Regular HMA meetings serve as a platform for coordinating the work of regulatory authorities, exchanging experience and discussing strategic directions for the development of the European regulatory network.
This time the meeting was hosted by Ireland and organized by the HPRA, the national regulatory authority responsible for regulating medicinal products, medical devices, clinical trials and other health products.
The Future of the European Regulatory Network
One of the central topics of the meeting was shaping a vision for the development of the European medicines regulatory network for the next decade.
During the thematic discussions, participants focused on three key areas:
- The future of regulatory decisions and the evidence base. Use of real-world data, alignment of evidence requirements at different stages of medicinal product assessment, and stronger cooperation between regulatory authorities and bodies responsible for reimbursement decisions.
- Interaction and coordination of regulatory systems. Developing cooperation between authorities regulating medicinal products, medical devices and other health products, as well as making more effective use of shared expert and inspection resources.
- Institutional capacity and competencies of the future. Developing expert capacity, digital transformation, the use of artificial intelligence, knowledge management and improving the operating models of regulatory agencies.
The results of these discussions are to be taken into account in preparing the next strategy for the development of the European Medicines Agencies Network, covering the period from 2028.
An important emphasis of the discussions was combining the efficiency of regulatory procedures with scientific independence, transparency and public trust. Simplifying processes must not mean lowering the requirements for the quality and safety of medicinal products.
Legislative Changes and the Development of Regulatory Practices
The meeting program also covered preparations for implementing the new EU pharmaceutical legislation, and discussion of legislative initiatives on biotechnology (Biotech Act) and the regulation of medical devices (MDR/IVDR).
Particular attention was paid to developing joint audit programs, improving data management and digital interaction between agencies.
Other topics included the development of clinical trials in the EU, the activities of the Accelerating Clinical Trials in the EU (ACT EU) initiative and improvements to the EU Clinical Trials Information System (CTIS).
Cooperation with European Partners
As part of its participation in HMA, the Center’s delegation also held a separate meeting with representatives of the Swedish Medical Products Agency.
Swedish colleagues are important partners of the Center in developing the professional competencies of Ukrainian experts. In particular, with their support, training programs are organized that help Ukrainian specialists deepen their knowledge of European regulatory approaches and practices.
Such cooperation is of particular importance in the context of Ukraine’s preparation for implementing a new model of state regulation of medicinal products.
What Does This Mean for Ukraine?
Ukraine is preparing to establish the Ukrainian Pharmaceutical Agency and to move to a new model of state regulation of medicinal products in line with European standards.
In this process, it is important to take into account not only the current EU requirements but also how the European regulatory system will change in the coming years.
Participation in HMA meetings gives Ukrainian experts the opportunity to engage directly in professional discussions, learn about the practices of national agencies, develop partnerships and take this experience into account when preparing the future institutional model of the Ukrainian regulator.
At the same time, Ukraine has its own experience of ensuring the continuity of expert evaluation and preserving the key functions of the regulatory system under full-scale war. This experience may be useful for further professional exchange with European partners, in particular on institutional resilience and crisis preparedness.
The Center’s participation in the 125th HMA meeting and the development of bilateral cooperation with European agencies help prepare Ukrainian experts for future changes and for Ukraine’s further integration into the European medicines regulatory system.
