Türkiye 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, Türkiye has a clinical trial database, Clinical Trials Turkey. The trials registered and results posted on ClinicalTrials.gov with at least a site in Türkiye 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 |
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Clinical Trials Turkey | Mandatory National Database (includes Ethics Requirement) | NA | Populated via ClinicalTrials.gov |
Interventional (Phases 2-4) |
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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
- February 2022: Turkey Regulatory Update - Draft Regulation on Clinical Trials of Pharmaceuticals and Biological Products Turkish Medicines and Medical Devices Agency (TITCK), the regulatory agency of Turkey posted the following update on February 02, 2022: Within the scope of the efforts for the Turkey institution to be among the authorities listed by the World Health Organization, the Regulation on Clinical … Continue reading "February 2022: Turkey Regulatory Update"
- September 2021: Turkey Registry Update - New link available for registration Turkish Medicines and Medical Devices Agency (TITCK), the regulatory agency of Turkey posted the following update on 17 September 2021: As of 20 September 2021, EBS Provincial Health Transactions System, which provides service over https://ebs.titck.gov.tr, also serves at https://onlineislemler.titck.gov.tr. The same user name and password can be used by all … Continue reading "September 2021: Turkey Registry Update"
- 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"
References
- Clinical Trials Turkey. Clinical Trials Turkey. Published November 13, 2018. Accessed November 13, 2018.
- Clinical Trials Portal. Clinical Trials Portal. http://kap.titck.gov.tr/. Published November 13, 2018. Accessed November 13, 2018.