The Egyptian Drug Authority (EDA) recently achieved a significant milestone in the field of medicines regulation by achieving Maturity Level 3 (ML3) in the World Health Organization (WHO) Global Classification of Regulatory Authorities.
This achievement is a testament to Egypt’s commitment to ensuring the availability of safe, effective and high-quality medical products for its population, as highlighted by WHO in a recent press release.
The achievement of ML3 follows a formal assessment process conducted by WHO, reflecting significant progress in strengthening the regulatory system for medical products across the African continent.
This achievement comes on top of Egypt’s achievement in March 2022, when it achieved ML3 for the regulation of vaccines (both locally produced and imported).
With this recent recognition, Egypt becomes the first African country to achieve ML3 status for the regulation of medicines and vaccines, as assessed by the WHO Global Assessment Tool.
The WHO assessment process, conducted using its Global Assessment Tool, assesses regulatory systems based on over 250 indicators. Maturity Level 4, the highest, represents an advanced regulatory system committed to continuous improvement.
Maturity Level 3 reflects a stable, operational and integrated regulatory system.
The achievement of ML3 status for the regulation of medicines by the EDA follows a rigorous process finalized in November 2024, carried out through close collaboration with the WHO Regional Office for the Eastern Mediterranean Region and coordination by the WHO Country Office in Egypt.
This milestone demonstrates Egypt’s strong commitment to strengthening its health system to ensure access to safe, effective and high-quality medical products for its population, as highlighted by Hanan Balkhy, WHO Regional Director for the Eastern Mediterranean Region.
Egypt’s achievement of maturity level 3 for the regulation of vaccines and medicines sets a powerful example for the region and beyond. It underscores the critical role of strong regulatory systems in achieving universal health coverage and health security.
WHO’s global assessment process is a key element of its programme to strengthen regulatory systems worldwide. It assesses essential functions such as product marketing authorization, market surveillance and adverse event detection.
Regulatory authorities that achieve maturity levels 3 and 4 may qualify as WHO-listed authorities, subject to further performance assessments.
Egypt’s achievement of ML3 for medicines regulation, coupled with an earlier milestone for vaccine regulation, demonstrates the country’s continued investment in strengthening its health system and its commitment to applying the highest standards of safety, efficacy, and quality to medicines and other medical products.