Egypt is one of the largest and most important markets in the Middle East and North Africa (MENA), with significant demand for pharmaceuticals, medical devices, and health products driven by a large population and healthcare development.
The Egyptian Drug Authority (EDA – الهيئة المصرية للدواء) is the national regulatory authority responsible for the registration, importation, distribution, quality control, pharmacovigilance, and post-market surveillance of medicines, medical devices, cosmetics, and related health products in Egypt. EDA aligns with international standards (WHO, ICH, IMDRF) and requires product registration, import permits, GMP compliance, quality certificates (CPP, GMP), Arabic labelling, and local agent representation. MedWisdom LifeScience provides expert regulatory affairs support to help global companies navigate EDA requirements, prepare compliant dossiers, secure timely registrations and import authorizations, and achieve successful market entry and sustained compliance in this key MENA market.
Get Egypt Compliance Support
Preparation of regulatory dossiers (CTD format), supporting documents (stability, preclinical/clinical data, GMP/CPP certificates), and quality review for EDA submissions.
End-to-end support for EDA registration of medicines, medical devices, cosmetics, and health products in Egypt.
Assistance with EDA import/export authorizations, batch release certificates, customs documentation, and special import permits.
Guidance on GMP documentation, quality assurance requirements, certificate support, and preparation for EDA quality inspections.
Setup of pharmacovigilance systems, adverse event reporting to EDA, periodic safety reporting, and risk management in Egypt.
Support for post-market monitoring, vigilance reporting, field safety corrective actions, and compliance with EDA post-registration requirements.
Arabic labelling review, EDA-specific requirements (patient information, packaging), mock-up preparation, and compliance support.
Support for local agent/representative requirements, EDA liaison, regulatory follow-up, and ongoing compliance management in Egypt.
Strategic market entry planning, EDA pathway guidance, regulatory intelligence on Egypt’s requirements, and risk mitigation support.
Partner with Medwisdom for expert, reliable, and compliant regulatory support in Egypt — from EDA product registration and import permits to pharmacovigilance, Arabic labelling, and sustained MENA market access.
Contact Our Egypt Regulatory Experts