Syria represents a challenging yet strategically located market in the Middle East, with ongoing demand for essential pharmaceuticals, medical devices, and health products despite regional complexities.
The Directorate of Drug Affairs and Narcotics Control (part of the Ministry of Health – وزارة الصحة) and the Syrian Arab Pharmaceutical Establishment oversee the regulation, registration, importation, distribution, and quality control of medicines, medical devices, and related health products in Syria. The authority manages product registration, import permits, quality assurance, pharmacovigilance, and post-market surveillance, often referencing WHO guidelines, regional standards, and simplified procedures for essential medicines. Foreign manufacturers face complexities in documentation, local representation or agent requirements, import licensing, and procedural timelines. MedWisdom LifeScience provides expert regulatory affairs support to help global companies navigate Syria’s requirements, prepare compliant dossiers, secure necessary approvals and import authorizations, and achieve successful market entry and compliance in this important regional market.
Get Syria Compliance Support
Preparation of regulatory dossiers, supporting documents (stability, preclinical/clinical data, GMP certificates, CPP), and quality review for Syrian Ministry of Health submissions.
End-to-end support for registration of medicines, medical devices, and related products with the Directorate of Drug Affairs and Narcotics Control.
Assistance with import/export authorizations, batch release certificates, customs documentation, and special import permits for regulated health products in Syria.
Guidance on GMP documentation, quality assurance requirements, certificate support, and preparation for Syrian quality inspections.
Setup of basic pharmacovigilance systems, adverse event reporting to Syrian authorities, and safety monitoring for registered products.
Support for post-market monitoring, vigilance reporting, product recalls, and compliance with Syrian post-registration obligations.
Arabic labelling review, Syrian-specific requirements (patient information, packaging), mock-up preparation, and compliance support.
Support for local agent/representative requirements, Ministry of Health liaison, regulatory follow-up, and ongoing compliance management in Syria.
Strategic market entry planning, Syrian regulatory pathway guidance, intelligence on evolving requirements, and risk mitigation support.
Partner with Medwisdom for expert, reliable, and compliant regulatory support in Syria — from Ministry of Health/SUPAM registration and import permits to pharmacovigilance, Arabic labelling, and sustained market access.
Contact Our Syria Regulatory Experts