“The Regulation on the Amendment of the Regulation on Clinical Trials of Pharmaceuticals and Biotechnological Products” has been published in the Official Gazette dated 6 July 2022 and numbered 31888 and entered into force.
With the amendment of the Regulation, in addition to various issues, regulations were made generally on the following subjects.
- The definition of coordinator has been amended, and some new definitions have been added to the Regulation.
- Some adjustments were made to the general principles of research.
- It has been stated that research applications and correspondences can only be made electronically, except in cases of force majeure.
- The 30-day periods have been changed to 30 working days.
- New articles on the first compatibility application process, exceptional research and obtaining opinion regarding the use of decision and report have been added after Article 12, where applications related to research are regulated.
- Regulations have been made regarding the changes that can be made during the conduct of clinical research.
- Within one year from the termination of the research in all centers, it is obligatory to submit the summary of the clinical research result report and a version of this summary prepared in a way that the volunteers can understand to the ethics committee and the Turkish Medicines and Medical Devices Agency.
- It has been regulated that samples of each batch of products manufactured or imported for research purposes, related information, and documentation, and all records related to the research should be kept for 14 years instead of 5 years.
- Regulations have been made on the authority and inspections of the Turkish Medicines and Medical Devices Agency, ethical committees, and the training required for the ethics committee members.
- In cases where there are no guidelines published by the Turkish Medicines and Medical Devices Agency, it is regulated that the institution can accept the guidelines published by the official health authorities of other countries or by international organizations, provided that it is announced on the official website of the Agency.
You may access the Regulation from the link below:
https://lnkd.in/drhuG4HJ