Turkey

Turkey

Clinical Research Portal (KAP)

Verified on September 8, 2021

Turkey has a clinical trial registry of its own, Clinical Research Portal (KAP). It is not a World Health Organization (WHO) recognized primary registry. The registration of clinical trials in a public registry is required as per Regulation on Clinical Trials of Medicinal and Biological Products issued by the Turkish Medicines and Medical Devices Agency. It is not mandatory to report the results. In addition, Turkey has a clinical trial database, Clinical Trials Turkey. The trials registered and results posted on ClinicalTrials.gov with at least a site in Turkey are available for public view on this database (Note: Previous link for this database has expired and the updated link is not yet available).

Registries at a Glance
Registry PHUSE Categorization Information to be Entered By Route of Data in Registry Study Type Language
KAP Academic/Patient Registries/Voluntary Sponsor Through a dedicated registration platform (process independent from clinical trial application)

Interventional

(Phase 1-4);

Observational

English
Clinical Trials Turkey Mandatory National Database (includes Ethics Requirement) NA Populated via ClinicalTrials.gov

Interventional

(Phases 2-4)
English
Registration and Results Requirements
Registry Activity Legal Requirement Timing
KAP Registration

Yes

Prior to first patient enrollment; after approval from the Turkish Medicines and Medical Devices Agency
Results

No

Not yet specified
Clinical Trials Turkey Registration

No

Not applicable (NA)-Populated from ClinicalTrials.gov
Results

No

NA-Populated from ClinicalTrials.gov

Registry Updates


  • June 2021: Turkey Regulatory Update - New Medical Device Regulations came into force As per the update posted on Turkish Medicines and Medical Devices Agency (regulatory agency of Turkey) on 14 June 2021, the “Medical Device Regulation” and the “In vitro Diagnostic Medical Device Regulation”, were published in the Turkish Official Gazette. The “Medical Device Regulation” prepared in full compliance with … Continue reading "June 2021: Turkey Regulatory Update"
  • December 2020: Turkey Regulatory Update - Revised Research Budget Form Turkish Medicines and Medical Devices Agency (TITCK), the regulatory agency of Turkey posted the following update on December 30, 2020: The Research Budget Form (KAD-FR-16) which is used to specify the financing of the research in the application files has been revised and put into effect as of 01.Jan.2021 to be … Continue reading "December 2020: Turkey Regulatory Update"
  • 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, … Continue reading "December 2020: Turkey Regulatory Update"

References


  1. Clinical Trials Turkey. Clinical Trials Turkey. Published November 13, 2018. Accessed November 13, 2018.
  2. Clinical Trials Portal. Clinical Trials Portal. http://kap.titck.gov.tr/. Published November 13, 2018. Accessed November 13, 2018.