The Turkish Medicines and Medical Devices Agency (“TİTCK”) published the Guidelines for Phase 1 Clinical Trial Research Centers (“Guidelines”) on June 24, 2019. The Guidelines provide 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 TİTCK-approved research and development centers that are equipped with the necessary means and that meet the set standards to perform emergency interventions. In this regard, sites where clinical trials will be conducted must have, at minimum, (i) the necessary staff and equipment appropriate to the nature of the study; (i) the facilities and means for storing and dispensing the investigational product; (iii) the means and equipment to provide appropriate care for research subjects and to 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 determine the standards relating to facility, personnel, equipment and quality systems for phase 1 clinical trial research centers and provide guidance for these centers regarding the risk evaluation/risk management processes.
Accordingly, sponsor companies and investigators must ensure that the phase 1 clinical trial centers meet the relevant standards within a year after the Guidelines enter into force.
The Guidelines are available on the TİTCK’s website (in Turkish).
The TİTCK continues to provide guidance for pharmaceutical companies. Pharmaceutical companies should regularly follow the TİTCK’s announcements, carefully review the requirements set forth in the Regulation and ensure the research centers meet the clinical trial conditions under the Regulation.