The Egyptian Drug Authority (EDA) has attained Maturity Level 3 (ML3) for both medicines and vaccines regulation on Saturday 20 December.
This achievement makes Egypt the first country in Africa to achieve ML3 for both categories. The Maturity level 3 reflects a stable, well-functioning, and integrated regulatory health system.
This latest recognition builds upon Egypt’s earlier success in March 2022, when it first achieved ML3 for vaccine regulation.
The WHO’s Global Benchmarking Tool (GBT) evaluates national regulatory authorities against over 250 indicators, assessing key functions such as product authorization, market surveillance, and adverse event detection.
Attaining ML3 signifies a stable and well-functioning regulatory system, essential for ensuring access to safe and effective medical products.
Hanan Balkhy, WHO Regional Director for the Eastern Mediterranean Region, highlighted to Ahram Online that this accomplishment underscores Egypt’s dedication to strengthening its health system.
“By achieving WHO maturity level 3 for vaccines and medicines regulation, Egypt has set a powerful example for the region and beyond,” she stated.
The EDA’s success stemmed from a rigorous benchmarking process that involved close collaboration with the WHO’s regional and country offices.
This evaluation utilized the WHO’s GBT to assess the EDA’s regulatory systems against over 250 indicators, focusing on essential functions such as product authorization and market surveillance.
The process, completed in November 2024, confirmed the EDA’s adherence to high international standards, resulting in the attainment of Maturity Level 3 (ML3) for both medicines and vaccine regulation.
Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products, noted that this achievement recognizes Egypt’s sustained investment in its health system and its commitment to maintaining high safety and quality standards for medicines.
As the EDA Chairman, Ali El-Ghamrawy, pointed out that these dual accreditations are expected to attract foreign investment into the Egyptian pharmaceutical market and enhance the global reputation of Egyptian medicines.
He expressed optimism that this recognition would lead to increased demand for Egyptian pharmaceuticals across Africa and the Arab world.
