Turkey

The primary regulatory authority for health products in Turkey is the Turkish Medicines and Medical Devices Agency (TITCK), operating under the Ministry of Health. The principal legislative framework includes the Pharmaceuticals and Medical Preparations Law No. 1262, the Medical Devices Regulation aligned with EU MDR 2017/745 and IVDR 2017/746, and various TITCK communiqués governing digital health and diagnostics. Approval processes differ by product category: pharmaceuticals require a marketing authorization application reviewed by TITCK's relevant department, medical devices require conformity assessment and registration on the national TITUBB/UTS (Product Tracking System), and in vitro diagnostics follow a dedicated registration pathway. Turkey increasingly harmonizes its requirements with EU standards, though national procedures remain distinct.

A locally authorized representative (Yetkili Temsilci) based in Turkey is mandatory for all foreign manufacturers seeking market access. Pharmaceutical dossiers must generally follow the Common Technical Document (CTD) format, and TITCK accepts data packages referencing EMA or FDA approvals as part of an abridged or bibliographic application route in certain cases. Medical devices must bear CE marking as a prerequisite for registration, following the EU MDR and IVDR frameworks. Recent reforms include the full implementation of the UTS serialization and traceability system for pharmaceuticals and devices, updated digital health guidance covering Software as a Medical Device (SaMD), mandatory Turkish labeling requirements, and strengthened post-market surveillance obligations. TITCK has also introduced risk-based review pathways to expedite approval for innovative and critical-need products.

Public procurement in Turkey is predominantly centralized through the Ministry of Health (Sağlık Bakanlığı) and its affiliated body, the Public Hospitals General Directorate (KHGM). The Central Physician Appointment System and the Social Security Institution (Sosyal Güvenlik Kurumu, SGK) play critical roles: SGK manages reimbursement lists and pricing for pharmaceuticals and medical devices, and its positive list inclusion is a de facto prerequisite for public market access. Large-scale national tenders for pharmaceuticals, medical devices, and diagnostics are coordinated centrally, often through the Ministry of Health's procurement directorate, while individual public hospitals may conduct supplementary tenders within defined frameworks. All public procurement must comply with Public Procurement Law No. 4734, administered by the Public Procurement Authority (KİK). Price controls are strict, with reference pricing benchmarked against a basket of European countries for pharmaceuticals, and SGK negotiates device reimbursement prices directly.

The private healthcare sector in Turkey is substantial, comprising a large network of private hospitals, polyclinics, and pharmacy chains, and represents a significant parallel procurement channel operating through direct commercial agreements and distributor networks. Turkey is an upper-middle-income country and is not a primary recipient of donor-funded procurement mechanisms such as UNICEF Supply Division, the Global Fund, or Gavi for mainstream health products; however, limited donor engagement exists for specific public health programs. Local manufacturing is actively promoted through government industrial policy: the Ministry of Industry and Technology supports domestic health product production via incentives, and SGK reimbursement frameworks offer pricing advantages to locally manufactured products under the domestic production preference policy (yerli üretim teşviki). This policy is designed to reduce import dependency and stimulate investment in Turkey's health manufacturing ecosystem, creating a meaningful commercial incentive for companies that establish or partner with local production facilities.