The Turkish Pharmaceuticals and Medical Devices Authority (TİTCK) recently announced that the draft amendments to the Regulation on Clinical Trials of Pharmaceuticals and Biological Products (“Regulation“) and the European Commission’s Implementing Regulation Draft (“Draft Implementing Regulation“) regarding the nonmedical product groups listed in Annex 16 of Regulation (EU) 2017/745 on medical devices are open for public consultation.
Please click on the relevant link below for our specific notes regarding recent developments:
What are the Amendments to the Regulation on Clinical Trials of Pharmaceuticals and Biological Products?
On 2 February 2022, the TİTCK published the Draft Regulation on Clinical Trials of Pharmaceuticals and Biological Products (“Draft Regulation“). The Draft Regulation is available online here (in Turkish).
The main regulations introduced in the Draft Regulation are as follows:
- In cases where the clinical trial sponsor is residing abroad, a real person or legal entity legal representative residing in Turkey is required to be appointed. The legal representative is responsible for the sponsor’s compliance with the Regulation, and it is the addressee of all communications.
- In the event of a violation of the Regulation or approved trial protocol, which affects the safety and rights of the volunteers or the reliability and quality of the clinical trial data, the ethics committee and the TİTCK are required to be informed within seven days at the latest upon being informed of the violation.
- Treatments for life-threatening diseases and research on conditions that are accepted to seriously threaten public health by the World Health Organization or Turkey are stipulated among exceptional studies and are subject to special procedures and principles, such as evaluation in a shorter period.
- Within one year upon the completion of the research in all centers, the summary of the research result report and the version that the volunteers can understand will be reported to the ethics committee and the TİTCK.
- The minimum legal retention period for research records has been increased from at least five years to 25 years upon the completion of the research.
- The cases in which the TİTCK may suspend the research, cancel the research permit or request changes in the research have been amended. In this context, failing to carry out the research in accordance with the approved documents, the negative effects of the reliability and quality of the research data on the conduct of the research and failing to fulfill the application/notification requirements are set forth among such cases.
- Without prejudice to trade secrets and the protection of personal data, the TİTCK will publish information on the research, research results and, if necessary, summary evaluation reports.
Stakeholders can submit their opinions via firstname.lastname@example.org until the end of 10 February 2022.
Draft Commission Implementing Regulation (EU) is Open for Public Consultation
On 3 February 2022, the TİTCK announced that the Draft Implementing Regulation, which sets out the specifications for the nonmedical product groups listed in Annex 16 of Regulation (EU) 2017/745 on medical devices, is available for public consultation. You can access the Draft Implementing Regulation and submit your opinion here.
The Draft Implementing Regulation was issued for the implementation of Regulation (EU) 2017/745 on medical devices to which the Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation were prepared in full compliance.
The Draft Implementing Regulation sets out requirements such as risk management and clinical safety evaluation for products that are not for medical purposes, such as the materials used in cosmetic surgery (e.g., implants, dermal fillers and body sculpting equipment), as well as contact lenses, body hair removal devices and electrical brain stimulators. Accordingly, the risks that may arise during the distribution and use of the products and the necessary precautions to keep them under control, along with the rules for product labeling and usage instructions, are regulated.
Stakeholders will be able to submit their opinions on the Draft Implementing Regulation until 11 February 2022.
The TİTCK continues to invite companies and stakeholders operating in the healthcare industry to share their opinions on the regulatory developments. Companies can follow the TİTCK’s announcements and submit their views on the legislative changes, if any.