Egypt

Egypt regulates pharmaceutical products through the Egyptian Drug Authority (EDA), an independent national regulatory authority established by Presidential Decree No. 777/2019 and Law No. 151/2019. EDA succeeded the Central Administration for Pharmaceutical Affairs (CAPA) of the Ministry of Health and Population (MoHP) and reports directly to the Prime Minister. The EDA Chairman has authority for marketing authorisation decisions on the recommendation of the Permanent Technical Committee (PTC). Marketing authorisation is evidenced by a Drug Registration Certificate, valid for 10 years. EDA achieved WHO Maturity Level 3 (ML3) for medicines in 2022 — the first African regulatory authority to attain ML3 — and has applied for ML4. EDA operates Standard, Reliance and Verification pathways with formal recognition of Stringent Regulatory Authorities (US FDA, EMA, MHRA, Health Canada, TGA, PMDA, Swissmedic) and WHO Prequalification under EDA Reliance Guidelines. Egypt is a PIC/S applicant and an active participant in the African Medicines Regulatory Harmonisation (AMRH) initiative, the African Medicines Agency (AMA) treaty and the WHO EMRO regulatory network. Public-sector access runs via the Universal Health Insurance (UHI) System being phased in under Law No. 2/2018 (replacing the prior fragmented social health insurance schemes) and the General Authority for Health Insurance (GAHI). Pricing is heavily regulated — EDA's Pricing Committee sets ex-factory and retail prices using international reference pricing across a defined basket of countries.