Egyptian Drug Authority
EDA · Egypt · middle east
Egypt's Egyptian Drug Authority (formed 2019, replacing the older CAPA / Central Administration of Pharmaceutical Affairs) — leech therapy regulated as a medical device with parallel traditional-medicine context.
Regulatory Profile
- Agency type
- national regulator
- Region
- middle east
- Country
- Egypt
- Leech status
- medical device cleared
- Last ASH review
- 2026-05-25
- Website
- https://www.edaegypt.gov.eg
Relevant Regulation Codes
- Law No. 151 of 2019 — Establishment of the Egyptian Drug Authority
- Ministerial Decree No. 296 of 2009 — Medical devices regulation
- Pharmacy Practice Law No. 127 of 1955 (as amended)
Prescriber Requirements
- Egyptian Medical Syndicate-registered MD prescription required
- Nursing application under physician's order per Nursing Syndicate scope
- Hijama (cupping) practitioners are licensed under separate Ministry of Health programme; leech therapy is not part of hijama scope but operates alongside it
Supply Chain & GMP
EDA Medical Device Registration; importer requires Egyptian Drug Authority licensing. Arabic-language labelling mandatory.
Import/Export Rules
Import via EDA approval + General Authority for Veterinary Services clearance. CITES via EEAA (Egyptian Environmental Affairs Agency).
Reimbursement Context
Universal Health Insurance System (rolling out 2018–2032) covers inpatient procedures under DRG-style bundling; outpatient hirudotherapy is private-pay.
Key Regulatory Documents
ASH Editorial Notes
Egypt's traditional-medicine ecosystem (Tibb Nabawi / prophetic medicine) has cultural overlap with leech therapy via the hadith of al-Bukhari; legal practice remains regulated under modern biomedical pathways.
Related Jurisdictions
Israeli MoH — Israel
Israel's Ministry of Health (Misrad HaBri'ut) — leech therapy regulated under the Pharmacists' Ordinance with Medical Devices Division oversight; significant clinical use in reconstructive and microsurgery services.
SFDA — Saudi Arabia
Saudi Arabia's SFDA — leech therapy supervised under medical-device pathway, with Saudi Vision 2030 expansion of traditional/complementary medicine via NCCAM-KSA at the Ministry of Health.
SAHPRA — South Africa
South Africa's SAHPRA (created 2018, replacing the Medicines Control Council) — leech therapy regulated as a medical device under the Medicines and Related Substances Act; traditional-health practitioners under separate THP Council.
MOHAP — United Arab Emirates
UAE Ministry of Health and Prevention — federal authority over health products; leech-specific regulation has not been independently verified by ASH.