Results of the meeting of the Clinical Research Subcommittee of the European Business Association

22/ 01/ 2026

On 15 January, the Clinical Trials Subcommittee of the European Business Association held its first meeting of 2026. During the meeting, CTS members summarised the work completed in 2025 and outlined the key priorities for 2026. Particular attention was given to current initiatives of the Ministry of Health of Ukraine in the field of clinical research. One of the central issues discussed was the Ministry of Health’s announcement regarding a potential restriction that would limit the conduct of clinical trials exclusively to university hospitals. Members of the Subcommittee — including representatives of sponsors, CROs, and clinical trial sites — unanimously emphasised that such an approach contradicts international requirements and Good Clinical Practice (GCP) standards, does not align with current Ukrainian legislation, and would significantly reduce patients’ access to innovative therapies. Limiting clinical trials only to university hospitals would drastically narrow the pool of eligible patients due to a reduction in the number of potential clinical trial sites. Such actions could have substantial negative consequences for public health and for the development of the clinical research sector overall, diminishing Ukraine’s attractiveness and competitiveness as a location for clinical trials. The Association supports the development of university hospitals and academic science, recognising their important role in strengthening the quality of medical education. However, this development should not occur at the expense of other medical institutions that have demonstrated high-quality performance through decades of participation in international clinical trials, multiple audits by the State Expert Center, inspections by the FDA, EMA, and other leading regulatory authorities worldwide, as well as sponsors’ audits. These institutions continued to operate reliably even after February 2022, ensuring uninterrupted patient access to treatment and enabling the gradual initiation of new studies thanks to their strong reputation. Participation in clinical trials must remain open to experienced sites across the country, as a broad and regionally balanced network of investigative centres is essential for maintaining Ukraine’s competitiveness and ensuring efficient patient recruitment. As part of the regulatory agenda, the Subcommittee presented its work on proposals to the draft Ministry of Health order amending the current Order No. 690, which will remain in effect until the end of 2026. Active collaboration also continues with the Ministry of Health and the State Expert Center on shaping a new Procedure for Conducting Clinical Trials, which is expected to come into force on 1 January 2027 — simultaneously with the enactment of the Law of Ukraine “On Medicinal Products” and the launch of the unified regulatory authority, the State Control Body (ОДК). The Subcommittee submitted proposals to the draft document during three rounds of public consultation in 2025, and alignment work is ongoing. A separate part of the discussion focused on strengthening international communication and promoting Ukraine as a reliable location for clinical research. Despite the challenges of the full-scale war, findings from Subcommittee surveys and analyses conducted in 2022–2025 indicate stable trust in Ukraine among global sponsors. In 2026, the Subcommittee plans to further expand systematic engagement with international stakeholders and intensify efforts in this direction. The Subcommittee expresses its gratitude to the entire community for its trust, active participation, and contribution to the development of clinical research in Ukraine. Particularly meaningful was the opportunity to hold an in-person meeting for the first time since the beginning of the full-scale invasion. We are confident that new opportunities for collaboration, industry growth, and support for Ukrainian patients lie ahead. We extend our sincere gratitude to the Armed Forces of Ukraine! Together — towards victory and recovery!

One of the central issues discussed was the Ministry of Health’s announcement regarding a potential restriction that would limit the conduct of clinical trials exclusively to university hospitals. Members of the Subcommittee — including representatives of sponsors, CROs, and clinical trial sites — unanimously emphasised that such an approach contradicts international requirements and Good Clinical Practice (GCP) standards, does not align with current Ukrainian legislation, and would significantly reduce patients’ access to innovative therapies. Limiting clinical trials only to university hospitals would drastically narrow the pool of eligible patients due to a reduction in the number of potential clinical trial sites. Such actions could have substantial negative consequences for public health and for the development of the clinical research sector overall, diminishing Ukraine’s attractiveness and competitiveness as a location for clinical trials.

The Association supports the development of university hospitals and academic science, recognising their important role in strengthening the quality of medical education. However, this development should not occur at the expense of other medical institutions that have demonstrated high-quality performance through decades of participation in international clinical trials, multiple audits by the State Expert Center, inspections by the FDA, EMA, and other leading regulatory authorities worldwide, as well as sponsors’ audits. These institutions continued to operate reliably even after February 2022, ensuring uninterrupted patient access to treatment and enabling the gradual initiation of new studies thanks to their strong reputation. Participation in clinical trials must remain open to experienced sites across the country, as a broad and regionally balanced network of investigative centres is essential for maintaining Ukraine’s competitiveness and ensuring efficient patient recruitment.

As part of the regulatory agenda, the Subcommittee presented its work on proposals to the draft Ministry of Health order amending the current Order No. 690, which will remain in effect until the end of 2026. Active collaboration also continues with the Ministry of Health and the State Expert Center on shaping a new Procedure for Conducting Clinical Trials, which is expected to come into force on 1 January 2027 — simultaneously with the enactment of the Law of Ukraine “On Medicinal Products” and the launch of the unified regulatory authority, the State Control Body (ОДК). The Subcommittee submitted proposals to the draft document during three rounds of public consultation in 2025, and alignment work is ongoing.

A separate part of the discussion focused on strengthening international communication and promoting Ukraine as a reliable location for clinical research. Despite the challenges of the full-scale war, findings from Subcommittee surveys and analyses conducted in 2022–2025 indicate stable trust in Ukraine among global sponsors. In 2026, the Subcommittee plans to further expand systematic engagement with international stakeholders and intensify efforts in this direction.

The Subcommittee expresses its gratitude to the entire community for its trust, active participation, and contribution to the development of clinical research in Ukraine. Particularly meaningful was the opportunity to hold an in-person meeting for the first time since the beginning of the full-scale invasion. We are confident that new opportunities for collaboration, industry growth, and support for Ukrainian patients lie ahead.

We extend our sincere gratitude to the Armed Forces of Ukraine!
Together — towards victory and recovery!