Egyptian Drug Authority earns WHO ML3 in pharmaceutical regulation

EGYPT—The Egyptian Drug Authority (EDA) has earned the World Health Organisation’s (WHO) Maturity Level 3 (ML3) designation for medicines regulation.

This accomplishment marks a groundbreaking moment for the continent, as Egypt becomes the first African nation to reach this level for both medicines and vaccines regulation.

This milestone highlights Egypt’s leadership in advancing regulatory standards and underscores its commitment to strengthening African health systems.

The recognition comes shortly after similar acknowledgements by Africa CDC for Rwanda and Senegal, whose regulatory authorities also attained WHO Maturity Level 3.

In his remarks, Africa CDC Director General H.E. Dr. Jean Kaseya praised the Egyptian government and EDA, calling their achievement a source of pride for Egypt and the entire continent.

Dr. Kaseya emphasized that this progress aligns with the African Union’s Agenda 2063, which envisions a prosperous and self-reliant Africa.

He noted that strong regulatory frameworks are essential for ensuring access to safe, effective, and high-quality medical products, making Egypt’s progress a significant step forward.

Despite this success, Africa still faces a major challenge—no regulatory authority on the continent has yet achieved Maturity Level 4 (ML4), the highest global standard.

Dr. Kaseya stressed the importance of bridging this gap, as ML4 status is crucial for guaranteeing the safety and quality of high-risk medical products independently. Closing this gap will enhance Africa’s health security and resilience.

Dr. Kaseya reaffirmed Africa CDC’s commitment to supporting countries in their journey toward ML4 status. He noted that Egypt’s achievement demonstrates the impact of collaborative governance, adequate resources, and strong determination.

 Africa CDC plans to work closely with WHO, the African Medicines Agency (AMA), and member states to accelerate progress and establish ML4-level regulatory systems across the continent.

Egypt’s pharmaceutical sector, which produces over 90% of its medicines locally and exports to more than 100 countries, exemplifies the role of local manufacturing in building resilient health systems.

By achieving WHO ML3, Egypt sets a benchmark for other African nations, proving that adherence to international standards can strengthen local production and boost health security.

Africa CDC remains dedicated to partnering with AMA and supporting all African nations in building robust regulatory systems that meet international standards.

Egypt’s success stands as a powerful example of what can be achieved through collaboration, capacity building, and innovation.

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