# Egyptian Drug Authority (EDA)

Source: https://onco.cc/institutions/egyptian-drug-authority/  
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## TL;DR

Egypt's medicines regulator, created by a 2019 law, which registers cancer medicines, authorises clinical trials with the national ethics council, and can register a medicine already approved in Europe or the United States through a shorter reliance route.

## Summary

Law 151 of 2019, published in the Official Gazette on 25 August 2019, established the Egyptian Drug Authority and the Egyptian Authority for Unified Procurement together. Article 2 of the promulgating law states that the drug authority replaces the National Organization for Drug Control and Research, the National Organization for Research and Control of Biologicals and the other bodies that had supervisory jurisdiction over medical products.

WHO announced on 20 December 2024 that the authority had reached maturity level 3 for medicines regulation, after a benchmarking finalised in November 2024, having reached the same level for vaccines in March 2022; WHO describes Egypt as the first country in Africa to reach maturity level 3 for both.

Its guideline for biological products (code EDREX:GL.BioInn.001, version 5, effective 21 June 2026) sets a maximum of 120 working days for the normal registration track, 90 for the fast track, and 20 and 40 working days for the two reliance levels; its reliance guideline (EDREX.GL.Bioinn.002, version 2.0, effective 30 June 2026) requires the product to be approved by the European Medicines Agency and/or the US Food and Drug Administration and identical to the product approved there, and states that approval by a reference authority does not oblige the EDA to approve. Under Law 214 of 2020 on clinical medical research, its approval and that of the Supreme Council for Review of the Ethics of Clinical Medical Research are both needed for trials of new compounds.

## Fields

- Kind: Institution
- Last checked: 2026-11-04
- Also known as: EDA; Egyptian Drug Authority; هيئة الدواء المصرية
- City: Cairo, EG
- Type: government
- Website: https://edaegypt.gov.eg

## Sources

- Law 151 of 2019 establishing the procurement authority and the drug authority (EDA copy, English translation, PDF): https://edaegypt.gov.eg/media/mvfjomwa/law-151-of-2019.pdf
- WHO: Egypt's regulatory system reaches WHO maturity level 3 in medicines regulation (20 December 2024): https://www.who.int/news/item/20-12-2024-egypt-s-regulatory-system-reaches-who-maturity-level-3-in-medicines-regulation
- EDA: procedures for registration of biological products through reliance pathways, version 2.0 (2026, PDF): https://www.edaegypt.gov.eg/media/r4rpiosu/reliance-english-version-final-2-_2-2026.pdf
- EDA: guideline implementing decree 343 of 2021, version 5 (2026, PDF): https://edaegypt.gov.eg/media/lvkl4sds/343-guideline-english-version-2026.pdf
- Law 214 of 2020 regulating clinical medical research (EDA copy, English translation, PDF): https://edaegypt.gov.eg/media/zz0alwxy/law-214-of-2020_-to-cairo-legal_.pdf

## Connected records

- technologies: [Global oncology and access in low- and middle-income countries](https://onco.cc/technologies/global-oncology-access/)
- institutions: [Egyptian Authority for Unified Procurement, Medical Supply and Technology Management (UPA)](https://onco.cc/institutions/egypt-unified-procurement-authority/), [Universal Health Insurance Authority (UHIA), Egypt](https://onco.cc/institutions/egypt-universal-health-insurance-authority/)

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