The Egyptian Drug Authority participated in the African Medicines Regulatory Summit, alongside several African regulatory authorities and international organizations specializing in the development and regulation of pharmaceutical products and medical devices.
The participation comes within the framework of the EDA’s commitment to strengthening its regional and international presence and to exchanging expertise with African and global regulatory bodies, thereby reinforcing Egypt’s position as a leading regulatory hub on the continent.
During the summit, the EDA delivered several distinguished presentations that reflected its regulatory leadership and extensive expertise:
• Dr. Dalia Abu Hussein, General Manager of the General Administration of Quality Assurance, presented a lecture titled “From Establishment to Recognition: EDA Success Story Toward WHO ML3,” showcasing the Authority’s journey toward achieving WHO Maturity Level 3 (ML3) recognition from the World Health Organization.
• Dr. Mariam Magid Morris, Manager of the Administration of Human Product Variations, presented an overview of regulatory developments in product registration and the adoption of reliance pathways, in addition to participating in a panel discussion on enhancing local manufacturing and supporting the “Made in Africa” initiative.
• Dr. Abeer El-Bahery, General Manager of the General Administration of Pharmaceutical and Pharmacy Practice, and Dr. Moaz Massoud Ali, General Manager of the General Administration for Regulation of Marketing and Advertising Materials, participated in a workshop titled “Toward Better Self-Care in West Africa.” They highlighted Egypt’s pioneering experience in implementing the Over-the-Counter (OTC) system as a leading model that promotes safe pharmaceutical product use and supports the principles of responsible self-care.
• Dr. Samar Hamido, Manager of the Administration for Biological Product Registration, participated in a high-level session titled “Advancing Regulatory Convergence,” which addressed pathways for regulatory harmonization of biological products and vaccines across Africa.
• Dr. Omnia Ayman, Manager of the Biological Protocols Unit, showed a scientific presentation on the EDA’s methodology for evaluating clinical studies and its role in supporting local vaccine manufacturing readiness in accordance with the latest international standards.
In the field of digital transformation, the Central Administration of Pharmaceutical Policies and Market Access participated in a session titled “From Digitalization to AI: Toward Smarter Regulation.” The session highlighted the Authority’s AI-driven projects, such as the Smart Pharmaceutical Naming Assistant and the National Track & Trace System.
This section also included the participation of:
• Dr. Rehab Mehrez, General Manager of the General Administration of Pharmaceutical Publications and References, who spoke in the session “Smart Labeling in Action: Compliance & Technology.”
• Dr. Shaimaa Salah El-Sayed and Dr. Asmaa Yousry, who participated in the session “Scaling Artificial Intelligence for Smarter Regulation.”
• Dr. Nourhan El-Manzalawy, Head of the Monitoring and Decision Support Unit, who presented “Securing the Supply Chain: Egyptian Track & Trace Project Update.”
This participation reflects the Egyptian Drug Authority’s commitment to consolidating Egypt’s position as a regional hub for pharmaceutical regulation, and to supporting Africa’s efforts toward self-sufficiency in pharmaceutical products and medical supplies — contributing to the development of more efficient and sustainable healthcare systems across the continent.