# Turkish Medicines and Medical Devices Agency (TİTCK)

Source: https://onco.cc/institutions/titck/  
OnCo record `titck` (Institution). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Türkiye's national medicines regulator, which licenses every cancer medicine sold in the country, authorises clinical trials and can rely on the earlier assessments of other regulators.

## Summary

The Türkiye İlaç ve Tıbbi Cihaz Kurumu was created as an agency of the Ministry of Health, with its own budget and legal personality, by Decree-Law 663 published on 2 November 2011; its offices are at Söğütözü Mahallesi 2176. Sokak No:5, Çankaya, Ankara. Unlike a member state of the European Union, Türkiye licenses medicines nationally, so a cancer medicine approved in Europe or the United States still needs a Turkish licence (ruhsat) before it can be sold.

Under the Beşeri Tıbbi Ürünler Ruhsatlandırma Yönetmeliği of 11 December 2021, applications can be made all year but the licensing process can start only in February, May, August and November, according to the agency's capacity. A completeness check takes 30 days; the licensing process is then to be concluded within 210 days, a clock that stops while the agency waits for information from the company and excludes laboratory testing and outside assessments. A Priority Evaluation Board can give priority or high priority to products that are first in treatment or diagnosis, bring an innovation, or are needed for public health, and decides which products may apply for conditional or exceptional licences. A 2022 amendment added article 37/A on reliance: the agency may take into account earlier assessments by other regulators with comparable standards, and for such applications the 210-day period is 90 days.

A 2020 study of the agency's review process found that the median time from submission to approval for new active substances rose from 529 days in 2016 to 663 days in 2018, while the agency's own review time fell from 408 to 326 days and the time taken by companies rose from 137 to 268 days. The agency also authorises clinical trials and issues the off-label approvals that the Social Security Institution requires before it pays for a medicine outside its licence.

## Fields

- Kind: Institution
- Last checked: 2026-11-04
- Also known as: TİTCK; TITCK; Türkiye İlaç ve Tıbbi Cihaz Kurumu; Turkish Medicines and Medical Devices Agency
- City: Ankara, TR
- Type: government
- Website: https://www.titck.gov.tr

## Sources

- TİTCK: tarihçe: https://www.titck.gov.tr/kurumsal/tarihce
- Beşeri Tıbbi Ürünler Ruhsatlandırma Yönetmeliği (Resmî Gazete, 11 December 2021): https://www.resmigazete.gov.tr/eskiler/2021/12/20211211-5.htm
- Amendment adding article 37/A, reliance (Resmî Gazete, 24 September 2022): https://www.resmigazete.gov.tr/eskiler/2022/09/20220924-1.htm
- Koyuncu et al., Front Pharmacol 2020: https://doi.org/10.3389/fphar.2019.01557

## Connected records

- institutions: [Department of Cancer, Ministry of Health of Türkiye (Kanser Dairesi Başkanlığı)](https://onco.cc/institutions/tr-cancer-department/), [Social Security Institution of Türkiye (Sosyal Güvenlik Kurumu, SGK)](https://onco.cc/institutions/sgk-turkiye/)
- key papers: [Evaluation of the Performance of the Turkish Regulatory Agency: Recommendations for Improved Patients' Access to Medicines](https://onco.cc/key-papers/paper-koyuncu-titck-review-front-pharmacol-2020/)

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