The Africa Centres for Disease Control and Prevention (Africa CDC) Applauds Egypt’s Milestone Achievement in Medicines and Vaccine Regulation
The Africa Centers for Disease Control and Prevention (Africa CDC) congratulates the Egyptian Drugs Authority (EDA) for receiving the World Health Organization Medicines Regulatory Maturity Level 3 (ML3) designation, marking Egypt as the first African country to achieve this status for Drug and vaccine regulation. This remarkable milestone highlights Egypt’s leadership in promoting regulatory excellence and strengthening health security across the continent.
HE Dr. Jean Kaseya, Director General of the Africa Centers for Disease Control and Prevention, expressed his appreciation to the Egyptian government and EDA, saying: “Egypt’s achievements are a source of great pride not only for the country, but for the entire African continent. It marks a milestone in The African Union takes an important step forward in advancing Agenda 2063 and promoting health equity. This achievement underscores the transformative power of investing in strong regulatory systems, which are essential to ensuring access to high-quality, safe and effective medical products. It’s important.”
While celebrating this progress, the Africa CDC stressed that Africa remains the only continent without a regulatory agency that has reached WHO Maturity Level 4 (ML4), the highest standard for regulatory excellence. This gap highlights the urgent need for Africa to strengthen its capacity to independently ensure the safety, effectiveness and quality of high-risk medical products. Closing this gap is critical to enhancing the continent’s health security and resilience.
Dr. Kaseya reiterated Africa CDC’s commitment to addressing this critical gap: “We remain steadfast in our mission to support African countries in achieving ML4 status. Egypt’s progress towards achieving ML3 for medicines and vaccines is a strong testament to this What can be achieved with coordinated governance, resources and commitment? Africa CDC will continue to work closely with the World Health Organization, the African Medicines Agency, African Member States and other partners to accelerate this agenda and ensure that Africa is at the forefront. ML4 level supervision system will be implemented in the near future.”
WHO’s global benchmarking tool assesses the performance of national regulatory systems based on more than 250 indicators. With the title of ML3, Egypt is fully capable of moving towards ML4 and setting an example for other African countries.
Egypt’s pharmaceutical industry is a model of localized production of health and safety, with more than 90% of medicines produced domestically and exported to more than 100 countries. This achievement demonstrates the critical role of local manufacturing in building resilient and self-reliant health systems.
Africa CDC reaffirms its commitment to work with the American Medical Association and support all Member States in strengthening their health systems and regulatory frameworks. Egypt’s success demonstrates the power of cooperation, capacity building and compliance with international standards.
Distributed by APO Group on behalf of the Africa Centers for Disease Control and Prevention (Africa CDC).
