The Pharma Legal Handbook: Turkey

Turkey is one of the world's most significant pharmaceutical markets and a strategic priority for companies managing European, Middle Eastern and emerging market portfolios. The Turkish Medicines and Medical Devices Agency (TITCK) manages product registration, while the Social Security Institution (SGK) oversees reimbursement decisions.

Turkey's pricing system uses reference pricing from a defined basket of European countries, and the price expressed in Turkish Lira is subject to exchange rate adjustments that have had significant commercial implications. The SGK reimbursement framework involves a positive list with health technology assessment requirements for innovative medicines.

The Pharma Legal Handbook: Turkey provides comprehensive guidance on pharmaceutical regulation in Turkey, covering TITCK product registration, SGK pricing and reimbursement pathways, clinical trial requirements, pharmacovigilance obligations, manufacturing standards, marketing rules, and intellectual property protection.