Syria

Pharmacovigilance in Syria is overseen by the Ministry of Health through its pharmaceutical-control structures. The Ministry’s official pharmacovigilance requirements for registration or renewal, published on 13 April 2025, provide a dedicated circular for imported products together with a model covering pharmacovigilance tasks and responsibilities and a Summary of the Pharmacovigilance System Master File (PSMF). Applicants and MAHs should ensure that the applicable system information is prepared and submitted during registration or renewal. Suspected adverse reactions can be reported through the official electronic adverse-reaction reporting service, which directs reporters to the national VigiFlow e-reporting form. Accessible official material does not clearly publish universal numerical ICSR timelines, a Syrian-residency requirement for the responsible person, fixed PSUR/PBRER frequencies or a routine inspection cycle for every MAH; these points should be confirmed with the Ministry. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): PSMF Maintenance: Concept and Importance in Pharmacovigilance.