To ensure a unified approach to the application of the provisions of the updated Procedure for Conducting Clinical Trials of Medicinal Products, we provide information on issues arising among participants in the process.
The information was prepared based on the results of a working meeting held in June 2026 with the participation of specialists of the State Expert Center of the Ministry of Health of Ukraine, representatives of the European Business Association, the NGO "Ukrainian Association of Clinical Research", contract research organizations and other participants in the field of clinical trials.
During the dialogue, the parties discussed practical issues of applying certain provisions of the order of the Ministry of Health of Ukraine dated 10 March 2026 No. 302, which updated the "Procedure for conducting clinical trials of medicinal products and expert evaluation of clinical trial materials".
The consolidated answers will help sponsors, investigators, contract research organizations and other participants in the process to consistently apply the updated requirements in their practical work.
We remind you that the order of the Ministry of Health of Ukraine of 10 March 2026 No. 302 "On Approval of Amendments to the Procedure for Conducting Clinical Trials of Medicinal Products and Expert Evaluation of Clinical Trial Materials" was registered with the Ministry of Justice of Ukraine on 20 April 2026 under No. 546/45940, and it entered into force on 8 May 2026.
Detailed explanations are available in the "Current Information" section at the link: https://www.dec.gov.ua/materials/aktualna-informacziya/?role=applicant
