Minister of Health, Khaled Abdel Ghaffar, met with a World Health Organization (WHO) delegation to review ongoing cooperation with the Egyptian Drug Authority (EDA) as part of preparations for renewing its international accreditation at Maturity Level 3 (ML3) in 2026.
WHO Maturity Level 3, in the context of National Regulatory Authorities (NRAs) for medicines and vaccines, signifies a stable, well-functioning, and integrated regulatory system. This level indicates that the NRA has established a robust framework for regulating medical products, ensuring their safety, efficacy, and quality.
Health Ministry spokesperson Hossam Abdel Ghaffar said the visit is part of Egypt’s efforts to reach Maturity Level 4, the highest classification in vaccine and pharmaceutical manufacturing.
Egypt was the first African country to receive ML3 status from the WHO for its regulatory performance.
He noted that regular WHO-led training missions have confirmed the EDA’s strong commitment to ensuring the safety, quality, and effectiveness of locally produced and imported medicines.
A key factor in Egypt’s current accreditation, he added, is the authority’s post-vaccination monitoring system for side effects, which remains essential to the renewal process and boosts global confidence in Egypt’s pharmaceutical oversight.
The ML3 classification was awarded after an official assessment by international experts under WHO leadership.
It reflects Egypt’s dedication to meet top global regulatory standards and strengthens the country’s position as a regional hub for pharmaceutical production, export, and investment.
