International Memberships, Memoranda of Understanding, and Regional Partnerships
The Egyptian Drug Authority continues to strengthen its regional and international presence through strategic partnerships with counterpart regulatory authorities, membership in global regulatory organizations and networks, and active participation in regional initiatives that promote regulatory convergence and cooperation.
First: Memoranda of Understanding (MoUs) Signed by the Egyptian Drug Authority (EDA) with International Regulatory Authorities
1. Republic of Yemen
The EDA signed an MoU with the Supreme Board of Drugs and Medical Appliances (SBDMA), Republic of Yemen, on 21 January 2023.
2. Republic of Zimbabwe
The EDA signed an MoU with the Medicines Control Authority of Zimbabwe (MCAZ) on 13 May 2023.
3. Republic of South Africa
The EDA signed an MoU with the South African Health Products Regulatory Authority (SAHPRA) on 9 July 2023.
4. Democratic Republic of the Congo
The EDA signed an MoU with the Congolese Agency for Pharmaceutical Regulation (ACOREP) on 26 September 2023.
5. Federal Republic of Nigeria
The EDA signed an MoU with the National Agency for Food and Drug Administration and Control (NAFDAC) on 19 December 2023.
6. Republic of Cuba
The EDA signed an MoU with the Center for State Control of Medicines, Equipment and Medical Devices (CECMED) on 28 May 2024.
7. Republic of Zambia
The EDA signed an MoU with the Zambia Medicines Regulatory Authority (ZAMRA) in June 2024.
8. Republic of Rwanda
The EDA signed an MoU with the Rwanda Food and Drugs Authority (RFDA) in August 2024.
9. Republic of Madagascar
The EDA signed an MoU with the Ministry of Public Health (MSANP) on 28 October 2024.
10. Eight-Country Memorandum of Understanding among WHO Maturity Level 3 (ML3) Regulatory Authorities
The Eight-Country MoU, signed on 25 June 2025, brings together the following participating countries:
United Republic of Tanzania (TMDA), Republic of Ghana (Ghana FDA), Republic of South Africa (SAHPRA), Republic of Senegal (ARP), Republic of Rwanda (Rwanda FDA), Republic of Zimbabwe (MCAZ), the Federal Republic of Nigeria (NAFDAC).
The MoU establishes a regional framework for strengthening regulatory cooperation, promoting pharmaceutical policy coordination, and advancing regulatory convergence among the participating authorities.
The initiative contributes to harmonizing regional regulatory practices, promoting regulatory reliance and mutual recognition, and accelerating the registration and availability of safe, effective, and quality-assured medical products.
11. Republic of Senegal
The EDA signed an MoU with the Agence de Réglementation Pharmaceutique (ARP) on 21 July 2025.
12. Federative Republic of Brazil
The EDA signed an MoU with the National Health Surveillance Agency (ANVISA) on 30 July 2025.
13. Republic of Korea
The EDA signed an MoU with the Ministry of Food and Drug Safety (MFDS) on 9 September 2025.
14. Republic of Angola
The EDA signed an MoU with the National Medicines Regulatory Agency (ARMED) on 11 December 2025.
15. Republic of Türkiye
The EDA signed an MoU with the Turkish Medicines and Medical Devices Agency (TİTCK) in February 2026.
16. People's Democratic Republic of Algeria
The EDA signed an MoU with the National Agency for Pharmaceutical Products (ANPP) on 15 June 2026, on the sidelines of Africa Health ExCon.
17. Federal Republic of Somalia
The EDA signed an MoU with the National Medicines Regulatory Authority (NMRA) on 16 June 2026, on the sidelines of Africa Health ExCon.
18. Republic of Sierra Leone
The EDA signed an MoU with the Pharmacy Board of Sierra Leone (PBSL) on 17 June 2026, on the sidelines of Africa Health ExCon.
Second: International Memberships and Affiliations
- International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)
Observer — November 2021
Member — June 2023
- International Pharmaceutical Regulators Programme (IPRP)
Management Committee Member — May 2022
Vice-Chair — June 2024
- Global Harmonization Working Party (GHWP)
Member — November 2023
Technical Committee Co-Chair — December 2025
- World Health Organization Global Clinical Trials Forum (WHO-GCTF)
Member — October 2025
- United States Pharmacopeia (USP)
Member — April 2026
- European Directorate for the Quality of Medicines & HealthCare (EDQM)
Observer — December 2023
- International Cooperation on Cosmetics Regulation (ICCR)
Observer — October 2021
- International Coalition of Medicines Regulatory Authorities (ICMRA)
Associate Member — March 2022
- Official Medicines Control Laboratories (OMCL)
Associate Member — June 2025
- World Health Organization National Network for Biologicals (WHO NNB)
Associate Member — April 2024
- International Medical Device Regulators Forum (IMDRF)
Affiliate Member — October 2023
- Pharmaceutical Inspection Co-operation Scheme (PIC/S)
Pre-Accession Status
Third: Regional Leadership and Strategic Partnerships
The Egyptian Drug Authority plays a leading role in advancing regulatory integration, reliance, and technical cooperation at the international, regional and subregional levels through a range of strategic initiatives and institutional partnerships that strengthen regulatory convergence and system capacity.
- Recognition as a Regional Centre of Regulatory Excellence (RCORE)
August 2023
The Egyptian Drug Authority was designated by the African Union Development Agency (AUDA-NEPAD) Steering Committee under the African Medicines Regulatory Harmonization (AMRH) Programme as a Regional Centre of Regulatory Excellence (RCORE).
This designation recognizes the Authority’s excellence in medicines registration, regulatory inspection, vaccine testing and release, and clinical trial oversight, reinforcing its position as a continental regulatory reference authority.
- North Africa Medicines Regulatory Harmonization (NAMRH)
February 2025
The Egyptian Drug Authority chairs the Steering Committee of the North Africa Medicines Regulatory Harmonization (NAMRH) initiative under the African Union Development Agency (AUDA-NEPAD), following Egypt’s unanimous election for a three-year term.
This leadership role strengthens regional regulatory coordination and supports the harmonization of pharmaceutical regulatory practices across North Africa.
- WHO Maturity Level 3 National Regulatory Authorities in Africa (WHO-ML3 NRAs)
February 2025
The Authority participates in a collaborative framework established through a joint Memorandum of Understanding among eight African National Regulatory Authorities recognized by the World Health Organization as Maturity Level 3 (ML3), namely Tanzania, Ghana, Nigeria, South Africa, Zimbabwe, Senegal, and Rwanda. This framework aims to enhance regulatory reliance, harmonize regulatory practices, and support more efficient regulatory pathways for medicines and vaccines across participating authorities.
- African Medical Devices Forum (AMDF)
April 2025
The Authority participated in the leadership selection meeting for the African Medical Devices Forum (AMDF) under the African Union Development Agency – NEPAD, securing the Vice-Chair seat for a three-year term. The selection process witnessed strong competition among participating countries, reaffirming the confidence of African nations in Egypt’s leadership role and its ability to support and advance the medical devices sector across the continent.
- Smart Safety Surveillance (AU3S) Program
September 2025
The Egyptian Drug Authority was elected Vice-Chair of the Steering Committee of the Smart Safety Surveillance (AU3S) Program affiliated with the African Union Development Agency (AUDA-NEPAD).
The election was conducted with the participation of international regulatory organizations, including the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) and the World Health Organization (WHO). This election reflects the Authority’s strengthened leadership in pharmaceutical regulation and pharmacovigilance across Africa.
The program focuses on enhancing drug safety systems, strengthening early warning mechanisms, and improving risk management frameworks for medical products.
- Network of African Reliance Laboratories (NARL)
November 2025
The Egyptian Drug Authority was elected Vice-Chair of the Network of African Reliance Laboratories (NARL) during its inaugural meeting under AUDA-NEPAD and the African Medicines Quality Forum (AMQF).
The Egyptian National Laboratory for Biological Products Control is among 13 accredited laboratories across Africa, highlighting the Authority’s role in strengthening laboratory networks, regulatory reliance, and supporting the operationalization of the African Medicines Agency (AMA).
- WHO Regional Training Centre for Biomanufacturing
May 2026
Following a highly competitive international selection process for World Health Organization designation, The Egyptian Drug Authority was designated as a Regional Training Centre for biomanufacturing under the Eastern Mediterranean Region.
This designation places Egypt among six global training centres under WHO’s Biomanufacturing Workforce Development Initiative (BWTI), reflecting its advanced role in regulatory capacity building and pharmaceutical development.
- Joint Strategic Partnership Announcement between the Egyptian Drug Authority and Swissmedic
June 2026
The Egyptian Drug Authority held a high-level meeting with Swissmedic in Bern, Switzerland, chaired by Prof. Dr. Ali El-Ghamrawy, Head of the EDA, and Ms. Vinzenza Trivigno, CEO of Swissmedic.
The discussions focused on strengthening regulatory collaboration, exchanging scientific and technical expertise, and exploring opportunities for mutual learning. Both sides emphasized expanding future cooperation to enhance regulatory system efficiency, support the competitiveness of the Egyptian pharmaceutical sector, and reinforce the Authority’s growing regional and international role.