Addis Ababa, Ethiopia — 22 December 2024 – The Africa Centres for Disease Control and Prevention (Africa CDC) congratulates the Egyptian Drug Authority (EDA) on its historic milestone of earning the WHO’s Maturity Level 3 (ML3) designation for medicines regulation, marking Egypt as the first African nation to achieve this status for both medicines and vaccine regulation. This remarkable milestone highlights Egypt’s leadership in advancing regulatory excellence and strengthening health security across the continent.
H.E. Dr. Jean Kaseya, Director General of Africa CDC, commended the Egyptian government and the EDA, stating, “Egypt’s accomplishment is a source of immense pride–not only for the country but for the entire continent. It marks a significant step forward in advancing the African Union’s Agenda 2063 and promoting health equity. This achievement underscores the transformative power of investing in robust regulatory systems, which are critical for ensuring access to quality, safe, and effective medical products.”
While celebrating this progress, Africa CDC emphasizes that Africa remains the only continent without a regulatory authority that has achieved WHO Maturity Level 4 (ML4)–the highest standard in regulatory excellence. This gap underscores the urgent need to enhance Africa’s capacity to independently ensure the safety, efficacy, and quality of high-risk medical products. Closing this gap is critical for bolstering the continent’s health security and resilience.
Dr. Kaseya reiterated Africa CDC’s commitment to addressing this critical gap: “We are steadfast in our mission to support African countries in achieving ML4 status. Egypt’s progress in attaining ML3 for medicines and vaccines powerfully demonstrates what can be achieved through aligned governance, resources, and commitment. Africa CDC will continue to work closely with the WHO, AMA (African Medicines Agency), African Member States, and other partners to accelerate this agenda and ensure that Africa attains ML4-level regulatory systems in the near future.”
The WHO’s Global Benchmarking Tool evaluates the performance of national regulatory systems based on over 250 indicators. With its ML3 designation, Egypt is well-positioned to make further advancements toward ML4, setting a model for other African nations.
Egypt’s pharmaceutical industry exemplifies local production for health security, producing over 90% of its medicines domestically and exporting to more than 100 countries. This achievement showcases the crucial role of local manufacturing in building resilient and self-reliant health systems.
Africa CDC reaffirms its commitment to working with AMA and supporting all Member States in strengthening their health systems and regulatory frameworks. Egypt’s success is a testament to the power of collaboration, capacity-building, and adherence to international standards.
