Egypt’s achievement of WHO’s ML3 contributes to attaining SDGs

22 / 12 / 2024

By Marwa Nassar - -

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 achievement will support Egypt’s national health priorities and contribute to advancing global health and the sustainable development goals

This underscores Egypt’s commitment to ensuring the availability of safe, effective, and high-quality medical products for its population.

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 Dr 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.”

The WHO global benchmarking process is a key component of its programme to strengthen regulatory systems worldwide. It evaluates core functions such as product authorization, market surveillance and adverse event detection. Regulatory authorities that reach ML3 and ML4 may qualify as WHO-listed Authorities, subject to additional performance assessments.

“The attainment of WHO maturity level 3 for medicines regulation in Egypt, coupled with a previous milestone for vaccines regulation, is a recognition of the country’s sustained investment towards strengthening its health system and its commitment to ensuring that the highest standards of safety, efficacy and quality are applied to medicines and other medical products,” said Dr Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products. “Such dual recognition brings significant value to the people of Egypt and establishes a solid precedent for regulatory excellence on the African continent. WHO is proud to support such progress which underscores the vital role of strong regulatory systems in achieving universal health coverage and advancing global health equity.”

Effective regulation of medical products is essential for any well-functioning healthcare system, ensuring access to quality, safe, and effective medicines, vaccines, and other health products. Strong regulatory authorities play a critical role by performing functions such as rapid product authorization and robust safety monitoring, ultimately leading to better health outcomes.