Egypt Becomes First African Nation to Attain WHO Maturity Level 3

Egypt has attained maturity level 3 (ML3) for medicines regulation in the World Health Organization’s (WHO) classification of national regulatory authorities.

The ML3 status was granted following a rigorous benchmarking process using WHO’s Global Benchmarking Tool (GBT), which evaluates regulatory systems against over 250 indicators. This recognition builds upon Egypt's prior achievement in March 2022, when it reached ML3 for vaccines regulation, covering both locally produced and imported vaccines.

Egypt now stands as the first African country to achieve this level for both medicines and vaccines regulation.

The WHO benchmarking process evaluates essential regulatory functions, including product authorization, market surveillance, and adverse event detection. Regulatory authorities at ML3 and ML4, the highest maturity level, demonstrate robust, integrated systems committed to continuous improvement.

The Egyptian Drug Authority (EDA) led the effort to attain ML3, collaborating closely with WHO's regional and country offices. This recognition will enhance Egypt’s healthcare system by facilitating rapid product authorisation and ensuring rigorous safety monitoring.