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Legal Alerts

28/11/2019

TİTCK Updates Guidelines for Clinical Trial Applications

Legal Alerts
Healthcare
General

Recent Development

The Turkish Medicine and Medical Devices Authority (“TİTCK”) updated the Guidelines for Clinical Trial Applications to the Clinical Trials Department and the Guidelines for Clinical Trial Applications to the Ethics Committee. (“Guidelines”). The Guidelines will enter into force on December 1, 2019.

What’s New?

The TİTCK recently introduced the Clinical Trials Module to standardize clinical trial applications, ensure efficiency in time management and create an efficient database in the scope of the Electronic Process Management Project. In this respect, the module allows applicants to track their clinical trial applications and the TİTCK to manage these applications effectively. The module also allows relevant persons and applicants to access up-to-date clinical trial data through the Clinical Trials Portal. Accordingly, as of December 1, 2019, clinical trial applications falling within the TİTCK’s authority will be received through the Clinical Trials Module.

To ensure that the clinical trial applications to the Clinical Trials Department and Clinical Trials Ethics Committee are duly made in accordance with the new module, the TİTCK updated the guidelines for clinical trial applications.

The Guidelines are available here (in Turkish).

Conclusion

The TİTCK continues to provide guidance for companies involved in clinical trials. Accordingly, companies should carefully review the TİTCK’s guidelines, follow the TİTCK’s announcements and execute their clinical trial applications by following the TİTCK’s instructions.