The Ministry of Health of Ukraine has implemented new amendments to the Procedure for Conducting Clinical Trials of Medicinal Products and Examination of Clinical Trial Materials, effective from June 13, 2024.
Major Amendments:
- Reduced Examination Timeframes
- The review period for clinical trial materials related to advanced therapy medicinal products has been reduced from 90 days to 79 days, with a preliminary review of 15 days and a specialized review of 64 days.
- The review period for significant protocol amendments in trials involving advanced therapy medicinal products has been shortened from 79 days to 68 days. This includes an 11-day preliminary review and a 57-day specialized review.
- If additional consultations with experts are necessary, the examination period may be extended by up to 50 days, and applicants will be notified accordingly.
- Revised Insurance Obligations:
Clinical trial sponsors are now required to obtain insurance covering their liability for any harm caused to subjects (patients or healthy volunteers) during the trial. This requirement aligns with insurance class 13 under Article 4 of the Law of Ukraine “On Insurance,” replacing the previous mandate for a patient (volunteer) life and health insurance contract.
- Updated terminology:
The terminology for “subjects”, “sponsors” and “investigated” have been updated to “subject of research”, “sponsor of a clinical trial” and “investigated medicinal product”.
These changes are the result of the dedicated efforts by the EBA Clinical Trials Subcommittee. They were implemented to enhance the efficiency and speed of clinical trial evaluations while upholding stringent safety and compliance standards.
Important links:
- Amendments to the Procedure for Conducting Clinical Trials of Medicinal Products and Expert Evaluation of Clinical Trial Materials, access date: 17.10.2025
- Procedure for conducting clinical trials of medicinal products and expert evaluation of clinical trial materials – On the approval of the Procedure will be held… | dated 23.09.2009 No. 690 (rada.gov.ua)
If you are considering conducting clinical trials in Ukraine, our team is well-equipped to support you with all aspects of daily operations and to ensure full compliance with the new procedures. Feel free to contact us for more information and assistance.
