On 6 July 2022, amendments (Turkish language) made by the Turkish Medicines and Medical Devices Agency to the Regulation on Clinical Trials of Medicines and Biological Products were published in the Official Gazette numbered 31888.
The amendments:
- Introduce new provisions regarding the clinical trial application procedure, exceptional trials and the Agency's authority to obtain scientific opinion from a scientific consultancy committee while evaluating clinical trial applications.
- Define more precisely the scope of the Agency's inspection authority and regulate cases where the Agency is entitled to cancel, cease or amend the trial.
- Set forth clearer provisions on both legal and financial liability of clinical trials.
- Provide more detailed criteria for ethics committee members and ethics committees' working principles.
The amendments entered into force on the day of publication.
First published by Practical Law Life Sciences Monthly Newsletter in Jul 08, 2022.