EBA Clinical Trials Subcommittee meeting

09/ 10/ 2025

On October 2, 2025, the Clinical Trials Subcommittee of the European Business Association held a meeting where industry representatives discussed the current status of key initiatives, pressing challenges, and joint next steps to support the development of clinical trials in Ukraine. Subcommittee Project Updates Participants received updates on regular surveys of member companies and clinical sites, the quarterly CTS Digest, and the annual information letter. These tools help stakeholders stay informed about regulatory changes and support the positive momentum of clinical trial recovery in Ukraine amid the ongoing full-scale war. Law on Lobbying The meeting addressed the new legislative requirements introduced by the Law of Ukraine “On Lobbying,” effective from September 1, 2025. The Subcommittee and companies discussed the necessary actions to ensure transparent and effective engagement with government authorities and legislators. Law on Medicinal Products & Establishment of the State Control Body (SCB) Special attention was given to preparations for the implementation of the new Law “On Medicinal Products” starting January 1, 2027, and the launch of a unified regulatory authority — the State Control Body (SCB). The Ministry of Health presented a roadmap for SCB establishment, the status of regulatory act development, and the launch of the Twinning project in cooperation with the European Commission. Participants discussed transition risks and the need for the Subcommittee to prepare proposals for amendments to the Law by the end of 2025, in line with the Ministry’s timeline. Logistical Challenges In an open discussion format, companies addressed practical issues such as import/export of clinical trial equipment, waste disposal and the need for relevant regulatory acts, and the requirements of the State Expert Center regarding the list of medical devices and related materials. The Clinical Trials Subcommittee sincerely thanks all participants for their active engagement, professional contributions, and collaborative spirit. Through consolidated expert efforts, we continue shaping a transparent, predictable, and effective regulatory environment for the advancement of clinical trials in Ukraine.

Subcommittee Project Updates

Participants received updates on regular surveys of member companies and clinical sites, the quarterly CTS Digest, and the annual information letter. These tools help stakeholders stay informed about regulatory changes and support the positive momentum of clinical trial recovery in Ukraine amid the ongoing full-scale war.

Law on Lobbying

The meeting addressed the new legislative requirements introduced by the Law of Ukraine “On Lobbying,” effective from September 1, 2025. The Subcommittee and companies discussed the necessary actions to ensure transparent and effective engagement with government authorities and legislators.

Law on Medicinal Products & Establishment of the State Control Body (SCB)

Special attention was given to preparations for the implementation of the new Law “On Medicinal Products” starting January 1, 2027, and the launch of a unified regulatory authority — the State Control Body (SCB).

The Ministry of Health presented a roadmap for SCB establishment, the status of regulatory act development, and the launch of the Twinning project in cooperation with the European Commission. Participants discussed transition risks and the need for the Subcommittee to prepare proposals for amendments to the Law by the end of 2025, in line with the Ministry’s timeline.

Logistical Challenges

In an open discussion format, companies addressed practical issues such as import/export of clinical trial equipment, waste disposal and the need for relevant regulatory acts, and the requirements of the State Expert Center regarding the list of medical devices and related materials.

The Clinical Trials Subcommittee sincerely thanks all participants for their active engagement, professional contributions, and collaborative spirit.

Through consolidated expert efforts, we continue shaping a transparent, predictable, and effective regulatory environment for the advancement of clinical trials in Ukraine.