The Africa Centres for Disease Control and Prevention (Africa CDC) has recently praised the Egyptian Drug Authority (EDA) for achieving the WHO’s Maturity Level 3 (ML3) designation for medicines regulation. This significant accomplishment makes Egypt the first African nation to reach this status for both medicines and vaccine regulation, showcasing the country’s leadership in advancing regulatory excellence and enhancing health security across the continent.
Dr. Jean Kaseya, Director General of Africa CDC, commended the Egyptian government and the EDA for their achievement, stating that it is a source of immense pride for not only Egypt but the entire continent. This milestone signifies a major step forward in advancing the African Union’s Agenda 2063 and promoting health equity. Dr. Kaseya highlighted the importance of investing in robust regulatory systems to ensure access to quality, safe, and effective medical products.
Despite Egypt’s success in reaching ML3, Africa CDC points out that Africa still lacks a regulatory authority that has achieved the highest standard of regulatory excellence, ML4. This gap underscores the urgent need to strengthen Africa’s capacity to independently guarantee the safety, efficacy, and quality of high-risk medical products, which is crucial for enhancing the continent’s health security and resilience.
Dr. Kaseya reaffirmed Africa CDC’s commitment to supporting African countries in achieving ML4 status, citing Egypt’s progress as a model for other nations to follow. The organization will continue to collaborate with the WHO, African Medicines Agency (AMA), African Member States, and other partners to accelerate this agenda and ensure that Africa attains ML4-level regulatory systems in the near future.
Egypt’s pharmaceutical industry serves as a prime example of local production for health security, with over 90% of medicines being produced domestically and exported to more than 100 countries. This achievement underscores the vital role of local manufacturing in building resilient and self-reliant health systems.
Africa CDC remains dedicated to working with AMA and supporting all Member States in strengthening their health systems and regulatory frameworks. The success of Egypt serves as a testament to the power of collaboration, capacity-building, and adherence to international standards in advancing healthcare across the continent.
This article was distributed by APO Group on behalf of Africa Centres for Disease Control and Prevention (Africa CDC) and highlights the importance of regulatory excellence in ensuring access to quality healthcare products and promoting health security in Africa.
