The Africa Centres for Disease Control and Prevention (Africa CDC) has commended the Egyptian Drug Authority (EDA) for achieving the World Health Organization’s (WHO) Maturity Level 3 (ML3) designation for medicines regulation. This milestone establishes Egypt as the first African country to achieve this status for both medicines and vaccine regulation, underlining its leadership in health security and regulatory excellence across the continent.
Egypt’s pharmaceutical sector is a beacon of health resilience, producing over 90% of its medicines locally and exporting to more than 100 countries. This achievement highlights the crucial role of local manufacturing in building self-reliant and robust health systems.
Dr. Jean Kaseya, Director General of Africa CDC, praised Egypt’s accomplishment, describing it as a proud moment for Africa. “This milestone represents a major step forward in advancing the African Union’s Agenda 2063 and promoting health equity. It underscores the transformative power of strong regulatory systems in ensuring access to safe, high-quality medical products,” he said.
While celebrating Egypt’s success, Africa CDC emphasized that Africa remains the only continent without a regulatory body meeting WHO’s highest standard, Maturity Level 4 (ML4). Addressing this gap is essential to ensuring the safety, efficacy, and quality of high-risk medical products and bolstering health resilience across Africa.
Dr. Kaseya reaffirmed Africa CDC’s commitment to helping African nations achieve ML4 status. “Egypt’s achievement of ML3 demonstrates what can be accomplished through aligned governance, resources, and commitment. We will continue working with the WHO, the African Medicines Agency (AMA), Member States, and partners to accelerate progress toward ML4 systems across Africa.”
Egypt’s success serves as a model for other African nations. With its ML3 designation, the country is well-positioned to progress toward ML4, leveraging the WHO’s Global Benchmarking Tool, which assesses regulatory systems based on over 250 indicators.
Africa CDC reiterated its dedication to supporting Member States in strengthening health systems and regulatory frameworks. Egypt’s achievement showcases the power of collaboration, capacity-building, and adherence to global standards in driving Africa’s health transformation.