The Turkish Medicines and Medical Devices Agency (“TITCK”) has published the Draft Medical Device Clinical Trials Regulation (“Draft Regulation”) on February 9, 2022.
The Draft Regulation aims to regulate the procedures and principles regarding post-marketing studies and medical device clinical trials and the protection of the rights of volunteers participating in these trials, within the framework of international agreements to which Turkey is a party, the European Union standards, and good clinical practices. With this respect, the Draft Regulation covers the studies after the devices are placed on the market, the medical device clinical trial, the places clinical trial is to be conducted, and the real and legal persons to carry out clinical research. However, retrospective studies and performance evaluation studies with in vitro diagnostic medical devices are excluded from the scope of the Draft Regulation.
According to the Draft Regulation, it is stipulated that the relevant provisions of the Medical Device Regulation (“Regulation”) are applicable regarding clinical trials and these provisions are to be applied together with the Draft Regulation concerning general principles of clinical research and clinical trials in vulnerable populations. For instance, in accordance with the international standards specified under the Regulation, it is stipulated that the research device should first be researched in a non-human experimental environment or on enough experimental animals. If it is not possible to conduct research on experimental animals, this should be proven on scientific grounds. Scientific data obtained as a result of experiments performed in a non-human experimental environment or on animals should provide sufficient evidence to carry out clinical trial of the medical device(s) to achieve the desired goal with the research. In addition, the Draft Regulation prohibits any research to disrupt the genetic structure of the germ cells of the volunteers.
With the Draft Regulation, the Clinical Trial Ethics Committees, whose structure and working procedures and principles are specified in the Regulation on Clinical Trials of Pharmaceuticals and Biological Products and are approved by the TITCK, are authorized for the scientific and ethical examination specified in the Regulation and for the monitoring and reviewing of the clinical trials.
In addition, regarding clinical trials in vulnerable populations, it is stipulated that for children to participate in clinical research, provided that the child can express their consent, the written consent of their parent - or if under guardianship, of their guardian - should be obtained in addition to the child’s consent. Also, provisions regarding informing the ethical committee and obtaining the ethical committee’s approval are stipulated under the Draft Regulation concerning research on children, pregnant or lactating women, persons with limited or reduced autonomy, who are within a certain hierarchical structure or whose ability to protect themselves has not yet developed, decreased, or completely disappeared due to economic, social, and medical reasons, or unconscious persons.
What is more, initiating and conducting clinical research is also regulated with the Draft Regulation. Within the framework of the Draft Regulation, for clinical trial applications to be made until the EUDAMED functionality date, the clinical trial sponsor should apply through the electronic application system of TITCK with the required documents. Clinical trials cannot be started without the permission of TITCK, if the online application is valid, TITCK would finalize the application within twenty (20) working days. With this respect, the EUDAMED functionality date is defined as six (6) months after the date of publication of the notification in the Official Journal of the European Union that EUDAMED is fully functional and meets the functional specifications by the Commission specified in the Regulation.
Another principal to be applied to keep the identity of the volunteers participating in the research confidential is, when reporting any adverse event or research-related data by the principal investigator or other researchers, the volunteer code given to each volunteer should be used instead of the volunteer's name and identifying information. The personal data of the volunteers should not be made public in any way.
In case there are changes in a clinical trial that are likely to have a significant impact on the safety, health, or rights of volunteers, or the consistency or reliability of clinical data from the research, the sponsor of the clinical trial should apply through the TITCK's electronic application system by the EUDAMED functionality date, along with the nature and reasons for the changes to be made. It is stipulated that significant changes cannot be implemented without the permission of the TITCK. If the application is validly made, TITCK would finalize the application within thirty (30) workdays.
The Draft Regulation also regulates the responsibilities of the sponsor and researchers. For example, the responsibilities of the sponsor include storage, distribution, and delivery to the research center in accordance with the specifications of the product after the manufacture or import of the research device, if necessary, the installation and maintenance, repair and calibration processes, and the maintenance of these conditions in the research center, and the collection of unused products from the research center and their return or appropriate disposal. The sponsor is also obliged to keep the records of all mentioned processes. Provided that a written contract is made, the sponsor may assign some of its duties to a research organization operating following scientific principles and good clinical practices. However, the transfer of tasks to such research organization would not eliminate the sponsor's legal and criminal liability for the assigned matters. Accordingly, it is stipulated in the Draft Regulation that the sponsor and the contracted research organization would be jointly liable for the results of the contracted works and transactions.
Additionally, sponsors and researchers are obliged to take the necessary emergency safety measures to protect volunteers whenever a situation that could affect volunteers’ safety arises during research or related to the development of investigational devices. In such scenario, the sponsor should notify the TITCK about such situation and the measures taken, via the electronic application system within seven (7) days.
Finally, the TITCK is authorized to carry out inspections with or without prior notice in terms of compliance with the provisions of Draft Regulation and other relevant legislation. The inspection may be targeted to clinical research carried out domestically or abroad, researchers, research centers, sponsors, their legal representatives, and contracted research institutions, places where research devices are manufactured, laboratories where research-related analyzes are made, ethical committees and all other parties within the scope of clinical research. In addition, it is also stipulated that the provisions of the Turkish Penal Code and other relevant legislation is applicable for those who violate the Draft Regulation.
Simge Kılıç, Esra Temur