Important Update: Changes to Clinical Trial Procedures in Ukraine Effective June 13, 2024

Jul 16, 2024

The Ministry of Health of Ukraine has announced the introduction of new changes to the procedures for conducting clinical trials of medicinal products and the examination of clinical trial materials from 13 June 2024. This welcome change is the result of the dedicated efforts by the EBA Clinical Trial Subcommittee of which Oximio worked hard alongside other industry players to bring about.

Key Changes:

  1. Reduced Examination Timeframes:
    • The timeframe for examining clinical trial materials for advanced therapy medicinal products has been shortened from 90 to 79 calendar days. This includes a 15-day preliminary examination and a 64-day specialised examination.
    • The examination period for significant amendments to the protocol of clinical trials involving advanced therapy medicinal products is now 68 calendar days, down from the previous 79. This period consists of an 11-day preliminary examination and a 57-day specialised examination.
    • The examination period can be extended by up to 50 calendar days for additional consultations with specialists. This will be communicated to applicants.
  2. Updated Insurance Requirements:
    • Sponsors of clinical trials must now conclude an insurance contract covering their liability to third parties for any harm caused to subjects (patients or healthy volunteers) during the trial. This is in accordance with insurance class 13 under Article 4 of the Law of Ukraine “On Insurance,” instead of the previous requirement for a patient (volunteer) life and health insurance contract.
  3. Terminology Updates:
    • The terminology for “subjects”, “sponsors” and “investigated” has been revised and will change to “subject of research”, “sponsor of a clinical trial” and “investigated medicinal product”.

View the complete Ministry of Health notification online.

These updates aim to streamline the clinical trial process, ensuring faster and more efficient evaluations while maintaining high standards of safety and compliance. For further details or questions regarding these changes, please don’t hesitate to contact us.