by Nurat Uthman
The World Health Organization (WHO) announced Friday that the Egyptian Drug Authority (EDA) has achieved Level 3 maturity for regulatory authorities.
Egypt has achieved a significant milestone in medicines regulation, attaining maturity level 3 (ML3) in the World Health Organization’s (WHO) global classification of national regulatory authorities. This accomplishment underscores Egypt’s commitment to ensuring the availability of safe, effective, and high-quality medical products for its population, WHO said in a statement.
This ML3 designation follows a formal benchmarking process conducted by WHO, marking significant progress toward strengthening the regulatory system for medical products across the African continent.
Notably, this achievement builds on Egypt’s earlier success in March 2022, when it reached ML3 for vaccines regulation (locally produced and imported).
With this latest recognition, Egypt becomes the first country in Africa to achieve ML3 for both medicines and vaccines regulation, as assessed by WHO’s Global Benchmarking Tool (GBT).
The WHO benchmarking process, conducted using its GBT, evaluates regulatory systems against more than 250 indicators. Maturity level 4, the highest level, represents an advanced regulatory system committed to continuous improvement.
Maturity level 3 reflects a stable, well-functioning, and integrated regulatory system.
The Egyptian Drug Authority (EDA) attained ML3 for medicines regulation following a rigorous benchmarking process finalized in November 2024, achieved through close collaboration with WHO regional office for the Eastern Mediterranean Region and coordination by WHO country office in Egypt.
“This milestone reflects Egypt’s firm commitment to strengthening its health system to ensuring access to safe, effective, and high-quality medical products for its population,” said Hanan Balkhy, WHO Regional Director for the Eastern Mediterranean Region.
“By achieving WHO maturity level 3 for both vaccines and medicines regulation, Egypt has set a powerful example for the region and beyond. This accomplishment underscores the critical role of strong regulatory systems in achieving universal health coverage and health security,” Balkhy added.
The WHO global benchmarking process is a key component of its program to strengthen regulatory systems worldwide. It evaluates core functions such as product authorization, market surveillance and adverse event detection.
