Turkey

Executive summary

Turkey (Türkiye) is one of the largest pharmaceutical markets in the EMEA region by volume but mid-sized by value due to the Euro-pegged price ceiling regime. The regulator is the Turkish Medicines and Medical Devices Agency (Türkiye İlaç ve Tıbbi Cihaz Kurumu — TİTCK), an autonomous body under the Ministry of Health established in 2011 (KHK No. 663). TİTCK regulates medicines, biologics, vaccines, medical devices, IVDs, cosmetics, and traditional herbal products. Turkey's regulatory framework is heavily harmonised with the EU acquis under EU candidate-country status. TİTCK accepts ICH-CTD/eCTD (eCTD mandatory since 2017 for new applications), is a PIC/S member (since 2018), an ICH observer, and operates the EBS (Elektronik Başvuru Sistemi) electronic submission portal. CPP from a reference country is typically required, but TİTCK does not yet operate a formal reliance pathway — foreign assessments accepted as supporting documentation rather than replacing local review. Pricing is one of the defining features of the Turkish market: Decree 2007/12325 sets a Euro-pegged price ceiling using a fixed reference exchange rate (last revised periodically; Euro reference rate has lagged actual exchange, compressing manufacturer margins). External reference pricing draws from a 5-country EU basket (France, Italy, Spain, Greece, Portugal) using the lowest ex-factory price. Reimbursement via the Social Security Institution (SGK) requires inclusion in the SUT (Sağlık Uygulama Tebliği — Health Application Communiqué) reimbursement list. Local manufacturing investment is heavily incentivised (Yerli Üretim policies).