The Africa Centers for Disease Control and Prevention (Africa CDC) has provided its support for Egypt to establish a regional biomanufacturing hub for North Africa.
The selection reflects Cairo’s commitment to advancing pharmaceutical manufacturing, particularly vaccine production, and strengthening biotechnology research, according to Ayman Ashour, the Egyptian minister of higher education and scientific research, adding that the achievement aligns with Egypt’s strategy to enhance health security both domestically and across Africa, aiming for vaccine self-sufficiency.
The selection of Egypt as the headquarters for the Regional Center for Capacity Building in Biomanufacturing (RCCN), in partnership with Morocco, follows the approval of Egypt’s proposal, submitted by the Unified Procurement Authority (UPA) under the Egyptian Vaccine Manufacturers Alliance (EVMA).
EVMA comprises the Unified Procurement Authority (UPA), the Academy of Scientific Research and Technology, the Egyptian Drug Authority, the Faculty of Pharmacy–Ain Shams University, the Faculty of Pharmacy–Cairo University, alongside vaccine manufacturers, including VACSERA, Biogeneric Pharma, Egyptian Vaccine City, GenVax, and Eva Pharma.
ML3 designation
This initiative is viewed as a significant step toward positioning Egypt as a biomanufacturing leader in Africa, reinforcing regional health security and vaccine production capabilities, the statement concluded.
The Egyptian Drug Authority (EDA) recently earned 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.
“Egypt’s accomplishment is a source of immense pride, not only for the country but for the entire continent,” said Jean Kaseya, MD, director general of Africa CDC. “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.”
However, Africa CDC also 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, noted Kaseya. “Closing this gap is critical for bolstering the continent’s health security and resilience,” he added.
Egypt’s pharmaceutical industry reportedly produces over 90% of its medicines domestically and exports to more than 100 countries. This achievement highlights the crucial role of local manufacturing in building resilient and self-reliant health systems.
