Clinical Trials

10/ 02/ 2026

On 10 February 2026, the Board of the Clinical Trials Subcommittee of the European Business Association held a working meeting with the newly appointed Director of the State Expert Centre of the Ministry of Health of Ukraine, Edem Adamanov, and representatives of the Centre. The meeting was attended by the Head of the Clinical Trials Subcommittee, Andrii Biliavskyi, Board Member Serhii Mykhailov, and Executive Director of the Subcommittee, Iryna Magdik. The main topic of discussion was the initiative of the Ministry of Health to introduce amendments to the Procedure for Conducting Clinical Trials. In particular, the draft order provides for a significant reduction in the list of institutions that can conduct clinical trials, allowing them to be carried out exclusively by university clinics and clinical bases of educational institutions in the field of healthcare. Representatives of the Association emphasised that the proposed changes not only contradict European approaches and the principles of ICH GCP, but also pose significant risks to the industry. In particular, the introduction of administrative restrictions may lead to a reduction in the number of trials, complications and delays in patient recruitment, decreased investment attractiveness, and the effective loss of Ukraine’s competitiveness (as previously highlighted by the Association in its earlier position). There is also a risk of reduced patient access to innovative treatment methods available through clinical trials. The Association’s position is that a centre’s capacity to conduct trials should be determined by its compliance with ICH GCP requirements, namely by functional capacity criteria — including a quality management system, appropriate infrastructure, qualified personnel, relevant research experience, etc. — rather than by its formal institutional status. This approach aligns with European standards and the requirements of Regulation (EU) No 536/2014 on equal and non-discriminatory access. The Association expresses its gratitude to the leadership and team of the State Expert Centre for the open and constructive dialogue, the opportunity to present the industry’s professional position, and their willingness to consider expert arguments. We hope that the Association’s proposals will be carefully reviewed and taken into account in further work. The EBA remains open to continued professional dialogue and ready to provide expert support to ensure the stable development of clinical trials in Ukraine, their harmonisation with European standards, and the safeguarding of the interests of patients, business and the state.

The meeting was attended by the Head of the Clinical Trials Subcommittee, Andrii Biliavskyi, Board Member Serhii Mykhailov, and Executive Director of the Subcommittee, Iryna Magdik.

The main topic of discussion was the initiative of the Ministry of Health to introduce amendments to the Procedure for Conducting Clinical Trials. In particular, the draft order provides for a significant reduction in the list of institutions that can conduct clinical trials, allowing them to be carried out exclusively by university clinics and clinical bases of educational institutions in the field of healthcare.

Representatives of the Association emphasised that the proposed changes not only contradict European approaches and the principles of ICH GCP, but also pose significant risks to the industry. In particular, the introduction of administrative restrictions may lead to a reduction in the number of trials, complications and delays in patient recruitment, decreased investment attractiveness, and the effective loss of Ukraine’s competitiveness (as previously highlighted by the Association in its earlier position). There is also a risk of reduced patient access to innovative treatment methods available through clinical trials.

The Association’s position is that a centre’s capacity to conduct trials should be determined by its compliance with ICH GCP requirements, namely by functional capacity criteria — including a quality management system, appropriate infrastructure, qualified personnel, relevant research experience, etc. — rather than by its formal institutional status. This approach aligns with European standards and the requirements of Regulation (EU) No 536/2014 on equal and non-discriminatory access.

The Association expresses its gratitude to the leadership and team of the State Expert Centre for the open and constructive dialogue, the opportunity to present the industry’s professional position, and their willingness to consider expert arguments. We hope that the Association’s proposals will be carefully reviewed and taken into account in further work.

The EBA remains open to continued professional dialogue and ready to provide expert support to ensure the stable development of clinical trials in Ukraine, their harmonisation with European standards, and the safeguarding of the interests of patients, business and the state.