In a major milestone for Africa’s healthcare sector, top national medicines regulatory authorities from across the continent have signed a landmark Memorandum of Understanding (MoU) to enhance collaboration and reliance on regulatory decisions.
The agreement, facilitated by the African Union Development Agency – New Partnership for Africa’s Development (AUDA-NEPAD) and Africa Centres for Disease Control and Prevention (Africa CDC), aims to expedite the approval process for medicines, vaccines, and medical devices, while fostering a supportive environment for local pharmaceutical production.
The MoU was signed by Ghana’s Food and Drugs Authority (FDA), Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC), Rwanda’s Food and Drugs Authority (FDA), Senegal’s Pharmaceutical Regulatory Agency (ARP), South Africa’s Health Products Regulatory Authority (SAHPRA), Tanzania’s Medicines & Medical Devices Authority (TMDA), and Zimbabwe’s Medicines Control Authority (MCAZ).
These regulatory bodies have achieved WHO Maturity Level 3 (ML3) status, signifying their adherence to globally recognized regulatory standards.
Enhancing Regulatory Efficiency and Access to Medicines
The agreement is designed to accelerate the approval process for essential medicines and medical products across Africa by allowing regulatory agencies to rely on each other’s assessments and decisions.
Through structured reliance, authorities can share evaluation reports, quality control data, and inspection outcomes, reducing duplication and speeding up approvals.
“This MoU comes at a critical moment as Africa works towards the operationalization of the African Medicines Agency (AMA),” said H.E. Nardos Bekele-Thomas, CEO of AUDA-NEPAD. “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 ensuring that safe and effective medical products reach our populations faster while strengthening our capacity to manufacture the medicines we need.”
Key Benefits of the Agreement
Faster Access to Medicines: By sharing regulatory decisions, the MoU will reduce delays in approving essential medicines, vaccines, and medical devices.
Strengthened Collaboration: The agreement fosters cooperation among Africa’s leading regulators, leveraging scientific expertise while maintaining independent oversight.
Optimized Resource Use: Countries with limited regulatory capacity can rely on stronger agencies, reducing costs and improving efficiency without compromising safety.
Enhanced Public Health Response: Streamlined regulatory processes will enable Africa CDC to respond more swiftly to public health emergencies, ensuring timely deployment of life-saving interventions.
Boosting Local Pharmaceutical Manufacturing
The agreement is also expected to accelerate Africa’s push towards self-sufficiency in medicine production.
By harmonizing regulatory processes, local manufacturers will face fewer bureaucratic hurdles, allowing for quicker market entry of domestically produced medicines.
H.E. Dr. Jean Kaseya, Director General of Africa CDC, emphasized the importance of the agreement in supporting the expansion of vaccine and pharmaceutical manufacturing on the continent.
“This MoU strengthens Africa’s ability to respond to public health crises by ensuring that regulatory processes are agile, efficient, and collaborative. It enhances our preparedness and response capabilities, enabling faster deployment of medical interventions during outbreaks.”
A Step Towards the African Medicines Agency (AMA)
This agreement is a significant achievement under the African Medicines Regulatory Harmonization (AMRH) initiative, which has been working to streamline medicine approvals across the continent.
It aligns with Africa’s broader agenda of establishing the African Medicines Agency (AMA), a pan-African regulatory body that will further harmonize medicine regulations and improve access to safe and effective medical products.
As Africa CDC and AUDA-NEPAD continue to champion regulatory harmonization, this MoU sets the stage for future collaborations, ultimately improving public health outcomes across the continent.
About Africa CDC
The Africa Centres for Disease Control and Prevention (Africa CDC) is the public health agency of the African Union, dedicated to strengthening health systems, improving disease surveillance, and coordinating emergency responses across member states.
Story by: Joshua Kwabena Smith
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