December 2020: Turkey Regulatory Update

Submission of annual notifications for the progress of clinical trials registered and not registered on Clinical Research Portal (KAP)

Turkish Medicines and Medical Devices Agency (TITCK), the regulatory agency of Turkey posted the following update on December 11, 2020:

Annual notifications covering the dates 01.Jan.2020 – 31.Dec.2020 must be made until 31.Jan.2021. As of 01.Jan.2021, annual notification is mandatory for all studies that are authorized by the institution and are ongoing (the final notification has not been submitted to the institution).

  • Studies enrolled in the Clinical Research Module: Annual notifications of trials registered in the Clinical Research Module will be made by filling the information in the module. If an annual notification form is submitted, these forms will not be taken into consideration. It is sufficient to submit only a cover letter and fill in the notification in the Module. The cover letter sample is available on the Clinical Research¬†page.
  • Clinical Trials Module registered to non-research: For annual notifications of trials not registered in the Clinical Research Module, using the annual notification form, the Electronic Application System will be submitted through the General Documents Application. Submission of the cover letter and annual notification form is sufficient. Cover letter and form sample can be accessed on the Clinical Research¬†page.

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