Getting medicines to those in need just got easier. Africa’s leading regulatory bodies have joined forces in a historic agreement to streamline drug approvals, cut costs, and boost local medicine production.
The Memorandum of Understanding (MoU), signed by seven leading National Regulatory Authorities (NRAs), on February 2, 2025, aims to strengthen Africa’s regulatory systems and boost local production of medical products.
According to a press release from Africa Centres for Disease Control and Prevention (Africa CDC) and the African Union Development Agency – New Partnership for Africa’s Development (AUDA-NEPAD), this will enhance collaboration among signatory agencies.
It will ensure quicker and more efficient approval processes while maintaining international safety and quality standards.
The MoU was signed by regulatory authorities from Ghana, Nigeria, Rwanda, Senegal, South Africa, Tanzania, and Zimbabwe—all recognized as WHO Maturity Level 3 agencies for their robust regulatory systems.
Under this agreement, these agencies will share data, inspection reports, and evaluation outcomes, making medicine approvals more efficient while lowering costs.
By eliminating unnecessary delays, the agreement fast-tracks access to life-saving medicines and vaccines, ensuring communities receive essential treatments without prolonged waiting periods.
Countries with limited regulatory resources will also benefit from the expertise of stronger agencies, enhancing efficiency without compromising public health standards.
“This MoU strengthens Africa CDC’s ability to respond swiftly to public health crises by ensuring that regulatory processes for medicines, vaccines, and diagnostics are more agile, efficient, and collaborative. By streamlining regulatory approvals, this partnership enhances Africa’s preparedness and response capabilities.” Highlights H.E. Dr. Jean Kaseya, Director General of Africa CDC.
AMA: A Boost for Local Vaccine and Drug Manufacturing
This MoU represents a monumental achievement for the African Medicines Regulatory Harmonization (AMRH) initiative and a significant step forward in strengthening Africa’s regulatory systems
Beyond accelerating medicine approvals, the agreement also aligns with the operationalization of the African Medicines Agency (AMA), which aims to create a unified regulatory system across the continent.
By simplifying approval processes, Africa will be able increase its local production of medicines, reduce reliance on imports and improve health security.
This move is expected to strengthen Africa’s pharmaceutical industry, making the continent more self-sufficient in the production of vaccines and medical products.
“For Africa to achieve a harmonized regulatory system, we must build trust in one another’s regulatory decisions. This agreement is a step forward in fostering collaboration and ensuring that safe and effective medical products reach our populations faster. It re-enforces the continent’s commitment on strengthening our capabilities to locally manufacture the medical products the continent needs to respond to health challenges.” Emphasized H.E. Nardos Bekele-Thomas, CEO of AUDA-NEPAD
Looking ahead, Africa CDC and AUDA-NEPAD remain committed to expanding regulatory collaboration and promoting local manufacturing. This MoU sets a strong foundation for future partnerships—ultimately paving the way for faster, safer, and more affordable healthcare solutions for millions of Africans.
By Gladys Asu Ngouana
