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Meeting of the EBA Clinical Trials Subcommittee

03/ 07/ 2025
  On 26 June 2025, a meeting of the Clinical Trials Subcommittee of the European Business Association took place. Participants discussed ongoing initiatives, challenges faced by companies, and the next steps toward achieving the strategic priorities set for 2025. Special attention was given to the Draft Procedure for Conducting Clinical Trials of Medicinal Products, as outlined in the Draft Order of the Ministry of Health of Ukraine Certain Issues Regarding the Conduct of Clinical Trials of Medicinal Products. Following feedback submitted by the business community, the draft was revised and re-published for public consultation on 18 June 2025. The ЕВА expresses its gratitude to representatives of the Ministry of Health of Ukraine and the State Expert Centre for considering numerous industry comments and recommendations. The Subcommittee is actively reviewing the updated version of the document and preparing additional proposals for further improvement, as the new Procedure will set the rules for the industry starting from 1 January 2027 — the effective date of the new Law of Ukraine “On Medicinal Products”. A separate focus of the Subcommittee’s work concerns amendments to the Criminal Code of Ukraine (Draft Law No. 11181-1 dated 03.05.2024), which aims to clarify the provisions on criminal liability for violations during clinical trials. The Clinical Trials Subcommittee actively participated in two meetings of the working group of the Verkhovna Rada Law Enforcement Committee, held on 9 May and 24 June 2025, regarding the preparation of the law for its second reading. Participants also discussed key topics related to the implementation of the new legislation, including the creation of a new state regulatory body and the launch of the national clinical trials registry. The Clinical Trials Subcommittee sincerely thanks representatives of member companies for their active participation, expert contributions, diligent daily work, and shared commitment to the development and recovery of the clinical trials sector in Ukraine.

On 26 June 2025, a meeting of the Clinical Trials Subcommittee of the European Business Association took place. Participants discussed ongoing initiatives, challenges faced by companies, and the next steps toward achieving the strategic priorities set for 2025.

Special attention was given to the Draft Procedure for Conducting Clinical Trials of Medicinal Products, as outlined in the Draft Order of the Ministry of Health of Ukraine “Certain Issues Regarding the Conduct of Clinical Trials of Medicinal Products”. Following feedback submitted by the business community, the draft was revised and re-published for public consultation on 18 June 2025.

The ЕВА expresses its gratitude to representatives of the Ministry of Health of Ukraine and the State Expert Centre for considering numerous industry comments and recommendations. The Subcommittee is actively reviewing the updated version of the document and preparing additional proposals for further improvement, as the new Procedure will set the rules for the industry starting from 1 January 2027 — the effective date of the new Law of Ukraine “On Medicinal Products”.

A separate focus of the Subcommittee’s work concerns amendments to the Criminal Code of Ukraine (Draft Law No. 11181-1 dated 03.05.2024), which aims to clarify the provisions on criminal liability for violations during clinical trials. The Clinical Trials Subcommittee actively participated in two meetings of the working group of the Verkhovna Rada Law Enforcement Committee, held on 9 May and 24 June 2025, regarding the preparation of the law for its second reading.

Participants also discussed key topics related to the implementation of the new legislation, including the creation of a new state regulatory body and the launch of the national clinical trials registry.

The Clinical Trials Subcommittee sincerely thanks representatives of member companies for their active participation, expert contributions, diligent daily work, and shared commitment to the development and recovery of the clinical trials sector in Ukraine.

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