Turkey

Pharmacovigilance in Türkiye is regulated by TİTCK through TÜFAM, under the national Regulation on the Safety of Medicines and the Turkish Good Pharmacovigilance Practices framework. Marketing-authorisation holders must maintain an effective pharmacovigilance and quality system; continuously employ a nationally appointed physician or pharmacist pharmacovigilance officer, a similarly qualified deputy and 24-hour contact arrangements. They must maintain an up-to-date Pharmacovigilance System Master File, known locally as the FSAD, at the Turkish pharmacovigilance centre and provide it to TİTCK within seven days when requested. All suspected serious adverse reactions occurring in Türkiye, including serious literature cases, must be submitted to TÜFAM within 15 days, and follow-up information is also due within 15 days. Foreign safety information that changes the benefit-risk balance must be reported immediately. PBRERs follow the applicable reference-date or default schedules and are submitted at renewal or when requested by TİTCK. MAHs must conduct signal detection, maintain risk-management systems, submit RMPs when specified, perform risk-based audits and remain inspection-ready. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): PSMF Maintenance: Concept and Importance in Pharmacovigilance.