Regulatory Services in Turkey

The Turkish Medicines and Medical Devices Agency (TITCK) of the Ministry of Health (MOHAP) is the authoritative body responsible for the regulation, inspection, and control of medicinal products and medical devices. The Registration Regulation of Human Medicinal Products dictates the registration and review procedures for medicinal products and devices intended for human use. Similar to most European and US procedures, the registration of a pharmaceutical product with Turkey’s Ministry of Health requires a license application and a GMP certificate. Regulatory compliance consulting services must also ensure thorough inspection of manufacturing sites to protect patient and employee safety, verifying that manufacturing processes are safe and repeatable. Hence, a GMP certificate is an integral component of the drug manufacturing process. These guidelines set by the Turkish authorities are in line with international standards, with the goal of providing safe and efficient access to medicinal products.

However, obtaining market authorizations for medicinal products takes significantly longer compared to other agencies such as the EMA . This delay stems from factors such as company response time, committee assessment timeline, and changes in registration regulations resulting in timelines increased by more than 50%. Additionally, Turkey’s nonmembership in the Pharmaceutical Inspection Convention and Cooperation Scheme requires the Turkish authority to negotiate with other countries for mutual recognition of certificates, further contributing to delayed approval processes.