Recent development

The Turkish Medicines and Medical Devices Agency (TİTCK) has announced changes to the application process for clinical research. The cover letter samples and application forms in relation to an application for clinical research have been amended, and new applications for clinical research must be made using these new samples and forms. The changes take effect as of August 2016 and further information is available here (in Turkish).

Background

Clinical research is defined as a scientific study that aims to obtain certain medical information with the participation of volunteers. It aims to indicate the safety and effectiveness of new medicines and medical devices before commencement of their common use, and also to provide scientific information about the development of new treatment methods as well as to determine any side effects of medications and medical devices. Clinical research is carried out with the permission of the Ministry of Health.

Conclusion

Applicants for clinical research should review the TİTCK’s website and ensure they use the new samples and forms in their applications.