The Turkish Medicines and Medical Devices Agency (“TİTCK”) published the Draft Guideline for Phase 1 Clinical Trial Research Centers (“Guideline”) on January 28, 2019. The Guideline provides guidance for sponsors, investigators and research centers regarding phase 1 clinical trials and audits conducted by the TİTCK.
Pursuant to the Regulation on Clinical Trials of Medicinal and Biological Products (“Regulation”), phase 1 clinical trials are conducted at research and development centers approved by the TİTCK, and equipped with the necessary means to perform emergency intervention and meeting standards set accordingly. In this regard, sites where clinical trials will be conducted must minimally have (i) necessary staff and equipment, appropriate to the nature of the study; (i) facilities and means for storing and dispensing the investigational product; (iii) the means and equipment to provide appropriate care to research subjects and transfer them to an advanced health institution if necessary and (iv) sufficient equipment to retain data and documents relating to clinical trial and subjects.
In this respect, the TİTCK aims to provide guidance for sponsor companies and investigators to ensure that the clinical trial centers meet the relevant standards. Companies can submit their feedbacks to the TİTCK until February 22, 2019, using the feedback form on the TİTCK’s website.
Guideline and feedback form are available on the TİTCK’s website (in Turkish).
The TİTCK continues to provide guidance for pharmaceuticals companies. Pharmaceuticals companies should regularly follow the TİTCK’s announcements, carefully review the requirements set forth in the Regulation and ensure the research centers to meet the conditions under the Regulation regarding clinical trials.