EDA (Egypt)

The Egyptian Drug Authority (EDA — هيئة الدواء المصرية) is Egypt's national regulator for human and veterinary medicines, biologicals, vaccines, medical devices, IVDs, cosmetics and dietary supplements. EDA was established under Law 151 of 2019 as an autonomous authority reporting to the Prime Minister, replacing the former Central Administration of Pharmaceutical Affairs (CAPA) which had operated inside the Ministry of Health. EDA runs the registration, GMP inspection, import licensing, pricing, advertising approval, pharmacovigilance and controlled-substance functions for the Arab Republic of Egypt.

Egypt reached WHO Maturity Level 3 for medicines regulation in 2022, placing EDA in the top tier of African medicines regulators. EDA operates reliance pathways for reference-authority approvals (FDA, EMA, MHRA, Health Canada, TGA, Swissmedic, PMDA) that shorten review timelines for innovator products, and CTD-aligned dossier review for generics and biosimilars. Medical devices are registered under a risk-classified scheme aligned to IMDRF; cosmetics and supplements follow their own frameworks under EDA's Central Administration for Cosmetics and Household Products.

GMP inspections of overseas manufacturers are risk-based, with EU / PIC/S / FDA GMP certificates supporting desk review and biologicals, sterile products and high-risk devices attracting on-site inspection. Egypt is not a PIC/S member but participates in African Medicines Regulatory Harmonisation (AMRH) initiatives and works closely with the WHO on the African Medicines Agency (AMA) build-out. V5 Ultimate maps directly onto EDA expectations — bound e-signatures, ALCOA+ batch records, deviation/CAPA workflow, and a per-country dossier pack — with the paired guide at /glossary/egypt-eda.