WHO added that the achievement builds on Egypt's earlier success in March 2022, when it reached ML3 for vaccine 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 statement noted. 

The WHO benchmarking process, conducted using its GBT, evaluates regulatory systems against over 250 indicators. Maturity level 3 reflects a stable, well-functioning, and integrated regulatory system per WHO's four-level maturity scale.

The statement pointed out that the EDA attained ML3 following a rigorous benchmarking process finalized in November 2024, achieved through close collaboration with the WHO regional office for the Eastern Mediterranean Region and coordination by the WHO country office in Egypt.

"This milestone reflects Egypt's firm commitment to strengthening its health system to ensure access to safe, effective, and high-quality medical products for its population," said Hanan Balkhy, WHO Regional Director for the Eastern Mediterranean Region.

"By achieving WHO maturity level 3 for 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," she added.

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.

Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products, said the recognition reflects the country's sustained investment in strengthening its health system.

Nakatani added that it also recognizes the country's commitment to ensuring that the highest safety, efficacy, and quality standards are applied to medicines and other medical products.

"Such dual recognition brings significant value to the people of Egypt and establishes a solid precedent for regulatory excellence on the African continent," the statement quoted Nakatani as saying.

Pharma investments looming
 

In a separate statement, EDA Chairman Ali El-Ghamrawy said the EDA obtained the two largest international accreditations from the WHO in the fields of vaccines and pharmaceuticals in just over four years.

El-Ghamrawy expected these accreditations to attract foreign investment into the Egyptian pharmaceutical market, enhance the global reputation of Egyptian medicines, and bolster confidence in their quality and efficacy.

He also expected increased demand for Egyptian pharmaceuticals from Africa, the Arab world, and the Middle East.

"With these accreditations, the EDA has become a global authority on Egyptian soil and an authority with international prestige and status in the field of regulation and control of pharmaceuticals and vaccines," the statement quoted El-Ghamrawy as saying.

He noted that Egypt will assist African countries wishing to benefit from the Egyptian experience.

According to WHO's 2022 report, fewer than 30 percent of the world's regulatory authorities are considered fully functioning and operational.