Egypt’s Ministry of Health and Population announced on Saturday that the Egyptian Drug Authority (EDA) officially received the Level 3 maturity certificate (ML3) for medicines and vaccines, according to the World Health Organization’s (WHO) classification for national regulatory bodies. This achievement marks a significant milestone in the country’s healthcare and regulatory systems.
Khaled Abdel Ghaffar, Deputy Prime Minister and Minister of Health and Population, described the certification as a major success for Egypt, underscoring its growing prominence in the global health sector. He highlighted that Egypt is the first country in Africa to achieve ML3 status, a distinction that will strengthen the national health system and attract increased investments to the Egyptian pharmaceutical market.
Minister Abdel Ghaffar emphasized that this achievement would not only elevate the reputation of Egyptian medicines but also enhance their global credibility. With the ML3 certification, Egyptian pharmaceutical products will gain increased recognition for their quality and effectiveness. This, in turn, is expected to boost demand for Egyptian medicines across Africa, the Arab world, and the Eastern Mediterranean region, opening new opportunities for export.
Hossam Abdel Ghaffar, the official spokesperson for the Ministry of Health, explained that the ML3 classification was granted after a thorough evaluation process led by a team of international experts from the WHO. The evaluation utilized “benchmarking,” a tool that assesses regulatory functions against more than 260 indicators, including product authorization, testing, market monitoring, and the ability to detect adverse events.
The spokesperson pointed out that the Egyptian Drug Authority had undergone several follow-up visits by international teams to monitor the implementation of the Authority’s institutional development plan. These visits confirmed the substantial progress made by the EDA in strengthening its regulatory framework. The final evaluation in November 2024 further validated the EDA’s commitment to ensuring the safety, effectiveness, and quality of both locally produced and imported medicines.
Abdel Ghaffar further stressed that regulatory systems achieving ML3 status are considered robust, stable, and highly integrated. These systems ensure that all medicines and vaccines approved for use meet the highest standards of quality, safety, and efficacy. He emphasized that this accomplishment reflects the EDA’s distinguished path and its commitment to supporting the growth of Egypt’s pharmaceutical sector while safeguarding public health.
This recognition by the WHO signals a new chapter for Egypt’s pharmaceutical industry, positioning the country as a leader in health regulation in Africa and beyond.
