Egypt has become Africa’s first nation to achieve international quality standards for both medicine and vaccine regulation, marking a milestone in the continent’s push for pharmaceutical independence.
The World Health Organisation (WHO) awarded Egypt’s Drug Authority a Maturity Level 3 designation, the second-highest rating for regulatory systems.
The classification recognises Egypt’s ability to ensure drug safety and quality control.
“Egypt’s accomplishment is a source of immense pride – not only for the country but for the entire continent,” said Dr. Jean Kaseya, director general of the Africa Centres for Disease Control and Prevention (Africa CDC).
Egypt’s pharmaceutical sector produces more than 90% of its medicines domestically and exports to over 100 countries.
However, no African nation has yet achieved the WHO’s highest regulatory rating, Maturity Level 4.
“We are steadfast in our mission to support African countries in achieving ML4 status,” Dr. Kaseya said. “Egypt’s progress powerfully demonstrates what can be achieved through aligned governance, resources, and commitment.”
The WHO evaluation examines more than 250 indicators of regulatory performance.
The certification positions Egypt as a model for other African nations working to strengthen their pharmaceutical oversight.
Africa CDC officials said the achievement advances the African Union’s Agenda 2063 goals for health system independence and demonstrates the importance of investing in regulatory infrastructure.
