On December 20, 2024, Egypt reached a major achievement in global health governance by attaining Maturity Level 3 (ML3) for medicines regulation, as part of the World Health Organization’s (WHO) global classification system for national regulatory authorities. This recognition highlights Egypt’s dedication to ensuring the availability of safe, effective, and high-quality medical products for its population.
Building on Previous Successes
The ML3 designation follows a formal benchmarking process carried out by WHO, marking a crucial step in strengthening regulatory systems for medical products across the African continent. This success builds on Egypt’s earlier accomplishment in March 2022, when it reached ML3 for vaccines regulation, including both locally produced and imported vaccines. With this latest recognition, Egypt becomes the first African nation to achieve ML3 for both medicines and vaccines regulation, as assessed by WHO’s Global Benchmarking Tool (GBT).
WHO’s Benchmarking Process
WHO’s benchmarking process evaluates regulatory systems based on more than 250 indicators, assessing critical functions such as product authorization, market surveillance, and adverse event detection. Maturity Level 4, the highest rating, represents an advanced regulatory system that prioritizes continuous improvement. ML3 indicates a stable, well-functioning, and integrated regulatory system that can support public health priorities effectively.
Collaboration and Commitment
The Egyptian Drug Authority (EDA) achieved ML3 for medicines regulation following a thorough benchmarking process finalized in November 2024. This accomplishment was made possible through close collaboration with WHO’s Regional Office for the Eastern Mediterranean and coordination by WHO’s country office in Egypt.
Dr. Hanan Balkhy, WHO Regional Director for the Eastern Mediterranean, emphasized the significance of this milestone: “This achievement reflects Egypt’s unwavering commitment to strengthening its health system and ensuring access to safe, effective, and high-quality medical products. By reaching WHO Maturity Level 3 for both vaccines and medicines regulation, Egypt sets a powerful example for the region and beyond, demonstrating the critical role of robust regulatory systems in achieving universal health coverage and health security.”
A Dual Achievement for Egypt
Dr. Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products, further highlighted the importance of this dual recognition: “The attainment of WHO Maturity Level 3 for medicines regulation in Egypt, alongside the prior achievement for vaccines regulation, underscores the country’s sustained efforts to strengthen its health system. This recognition not only benefits the people of Egypt but also sets a solid precedent for regulatory excellence across Africa. WHO is proud to support such progress, which demonstrates the vital role of strong regulatory systems in achieving global health equity.”
Impact on National and Global Health Goals
Egypt’s achievement will contribute significantly to advancing national health priorities and global health initiatives, including the United Nations’ Sustainable Development Goals. Effective regulation of medical products ensures the availability of safe, effective, and high-quality medicines and vaccines, crucial for a well-functioning healthcare system. Strong regulatory authorities, like Egypt’s, help improve health outcomes by enabling rapid product authorization and robust safety monitoring, ultimately benefiting public health.
