Turkey

The Turkish Medicines and Medical Devices Agency (TITCK), operating under the Ministry of Health, is the primary authority responsible for the regulation, licensing, and post-market surveillance of pharmaceuticals, medical devices, in vitro diagnostics, and digital health products in Turkey. The overarching legal framework is established by the Law on Pharmaceuticals and Medical Preparations (Law No. 1262) and supplementary regulations aligned with both national and European Union standards. Pharmaceutical products must obtain a Marketing Authorization (MA) through TITCK, while medical devices and IVDs are regulated under secondary legislation harmonized with EU MDR 2017/745 and IVDR 2017/746, requiring CE marking or equivalent conformity assessment. Digital health solutions are subject to evolving guidance, with software as a medical device (SaMD) increasingly assessed under the medical device framework.

Key submission requirements include the appointment of a local authorized representative or Marketing Authorization Holder (MAH) registered in Turkey, which is mandatory for foreign manufacturers. Pharmaceutical dossiers must follow the Common Technical Document (CTD) format, and TITCK accepts reliance pathways referencing approvals from the European Medicines Agency (EMA) or other recognized reference agencies, which can expedite review timelines. Medical device registrations are managed through the national ÜTS (Product Tracking System), and CE-marked devices generally benefit from a streamlined registration process. Notable recent reforms include TITCK's alignment with EU MDR requirements, the expansion of the electronic submission portal (e-başvuru), mandatory track-and-trace serialization for pharmaceuticals under the ITS (Drug Tracking System), and strengthened pharmacovigilance obligations. Turkey has also introduced fast-track pathways for innovative and orphan medicinal products.

Public procurement in Turkey is highly centralized and primarily governed by the Ministry of Health (Sağlık Bakanlığı) through its affiliated bodies, including the General Directorate of Health Investments and the Turkish Medicines and Medical Devices Agency. The Central Purchasing Body for health products, the Public Hospitals General Directorate (Kamu Hastaneleri Genel Müdürlüğü), conducts large-scale national tenders covering pharmaceuticals, medical devices, diagnostics, and consumables for public hospitals and health institutions. Procurement procedures are subject to the Public Procurement Law (Law No. 4734), overseen by the Public Procurement Authority (Kamu İhale Kurumu, KİK). Pharmaceutical pricing and reimbursement are determined by the Ministry of Health in conjunction with the Social Security Institution (Sosyal Güvenlik Kurumu, SGK), which manages the national reimbursement list (SUT) and applies reference pricing benchmarked against a basket of European countries.

The private healthcare sector in Turkey is substantial and growing, comprising private hospitals, pharmacy chains, and diagnostic laboratories that procure products independently through direct commercial agreements with distributors and manufacturers, outside the centralized tender framework. Turkey is an upper-middle-income country and does not typically rely on major donor-funded procurement channels such as UNICEF Supply Division, the Global Fund, Gavi, or USAID for mainstream health commodities; however, limited public health program collaborations with international organizations do occur in specific areas such as infectious disease and maternal health. Turkey maintains active local manufacturing preference policies, offering incentives for domestic production and, in some tender categories, applying price advantages or preferential scoring to locally manufactured products. The government has pursued strategic investments in pharmaceutical and medical device manufacturing capacity under national health industry development programs, encouraging technology transfer agreements and joint ventures with domestic producers.