Yemen represents an emerging market in the Middle East with potential demand for essential pharmaceuticals, medical devices, and health products, though the regulatory environment is influenced by regional challenges and reliance on international standards.
The Supreme Authority for Medicines and Medical Supplies (SUPAM – الهيئة العليا للأدوية والمستلزمات الطبية) is the primary regulatory body in Yemen responsible for the registration, importation, distribution, and quality control of medicines, medical devices, and related health products. SUPAM oversees product registration, import permits, quality assurance, pharmacovigilance, and post-market surveillance, often aligning with WHO guidelines and regional GCC standards due to Yemen’s participation in regional health initiatives. Foreign manufacturers face complexities in documentation, local representation requirements, and import procedures. MedWisdom LifeScience provides expert regulatory affairs support to help global companies navigate Yemen’s requirements, prepare compliant dossiers, secure necessary approvals and import authorizations, and achieve successful market entry and compliance in this challenging yet strategically important market.
Get Yemen Compliance Support
Preparation of regulatory dossiers, CTD format adaptation, supporting documents (stability, preclinical/clinical data, GMP certificates), and quality review for SUPAM submissions.
End-to-end support for SUPAM marketing authorization applications, registration of medicines, medical devices, and related products in Yemen.
Assistance with SUPAM import/export authorizations, batch release certificates, customs documentation, and special import permits for regulated health products.
Guidance on GMP requirements, quality assurance documentation, site certification support, and preparation for SUPAM quality inspections.
Setup of pharmacovigilance systems, adverse event reporting to SUPAM, periodic safety update reporting, and basic risk management in Yemen.
Support for post-market monitoring, vigilance reporting, field safety corrective actions, and compliance with SUPAM post-registration requirements.
Arabic labelling review, SUPAM-specific requirements (including patient information and packaging), mock-up preparation, and compliance support.
Acting as local authorized representative, SUPAM liaison, regulatory follow-up, and ongoing compliance management in Yemen.
Strategic market entry planning, SUPAM pathway guidance, regulatory intelligence on Yemen’s evolving requirements, and risk mitigation support.
Partner with Medwisdom for expert, reliable, and compliant regulatory support in Yemen — from SUPAM product registration and import permits to pharmacovigilance, Arabic labelling, and sustained market access.
Contact Our Yemen Regulatory Experts