The African Union Development Agency – New Partnership for Africa’s Development (AUDA-NEPAD) and Africa Centres for Disease Control and Prevention (Africa CDC) proudly announce the signing of a Memorandum of Understanding (MoU) among Africa’s WHO Maturity Level 3 National Regulatory Authorities (NRAs).
This agreement constitutes a significant milestone in enhancing regulatory frameworks across the continent by fostering collaboration and reliance on regulatory decisions among the signatory agencies. It further establishes an enabling environment for the local production of medical products.
The primary objective of this MoU is to create a structured framework for reliance on regulatory decisions, expediting the approval processes for medicines, vaccines, and medical devices, as well as facilitating collaboration on vaccine lot release functions.
The MoU was signed by the following regulatory bodies: Ghana’s Food and Drugs Authority (FDA), the National Agency for Food and Drug Administration and Control (NAFDAC) of Nigeria, Rwanda Food and Drugs Authority (FDA), the Senegalese Pharmaceutical Regulatory Agency (ARP), South African Health Products Regulatory Authority (SAHPRA), Tanzania Medicines & Medical Devices Authority (TMDA), and the Medicines Control Authority of Zimbabwe (MCAZ).
Through this agreement, the signatories commit to streamlining application submission and evaluation processes to facilitate efficiency, reduce costs, and ensure timely regulatory decision-making. These objectives will be achieved through information sharing, work-sharing, and reliance—either partially or fully—on assessment reports generated by the participating authorities. The MoU also establishes mechanisms to ensure that authorized products and clinical trials comply with internationally accepted regulatory standards.
Key Benefits of the MoU
- Efficient Regulatory Processes: The agreement enables the sharing of assessment reports, Quality Control laboratory results, and Good Manufacturing/Clinical Practice (GMP/GCP) inspection reports among the signatories, reducing redundancy and enhancing operational efficiency.
- Timely Access to Medicines: By leveraging shared regulatory decisions, the MoU aims to accelerate access to essential medicines, vaccines, and medical devices across Africa.
- Strengthened Collaboration: This framework fosters a cooperative environment where regulatory authorities can benefit from each other’s scientific expertise while maintaining their independent regulatory mandates.
- Optimized Resource Utilization: Countries with limited regulatory capacity can rely on more established agencies, thereby enhancing their regulatory capabilities without compromising public health standards.
Under this framework, reliance may be unilateral, bilateral, mutual, or multilateral, allowing each authority to utilize shared regulatory data based on its national requirements while ensuring adherence to regional and international regulatory standards.
A Milestone for AUDA-NEPAD’s AMRH, Africa CDC, and the Future of AMA
This MoU represents a landmark achievement for the African Medicines Regulatory Harmonization (AMRH) initiative and a crucial step in fortifying Africa’s regulatory infrastructure. By fostering collaboration among National Regulatory Authorities, the agreement supports the broader continental agenda of ensuring timely access to safe and effective medical products. It also aligns with the ongoing transition toward the operationalization of the African Medicines Agency (AMA), reinforcing the necessity of harmonized regulatory processes to strengthen Africa’s healthcare systems.
H.E. Nardos Bekele-Thomas, CEO of AUDA-NEPAD, emphasized the significance of this agreement, stating:
“This MoU comes at a critical moment as AMRH prepares for the transition towards AMA. 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 reinforces the continent’s commitment to strengthening our capabilities for the local manufacture of medical products necessary to address health challenges.”
H.E. Dr. Jean Kaseya, Director General of Africa CDC, further noted that the signing of the MoU by the WHO Maturity Level 3 National Regulatory Authorities represents a significant milestone in Africa CDC’s efforts to expand local vaccine and health commodity manufacturing. He added that this agreement enhances Africa CDC’s capacity to respond rapidly to public health crises by streamlining regulatory approvals for medicines, vaccines, and diagnostics. By making regulatory processes more agile, efficient, and collaborative, this partnership strengthens Africa’s preparedness and response mechanisms, ensuring the timely deployment of life-saving medical interventions during health emergencies.
In collaboration with AUDA-NEPAD and AMA, Africa CDC continues to champion regulatory harmonization and local medical product manufacturing. This MoU establishes a precedent for future cooperation, ultimately advancing Africa’s capacity to regulate medical products efficiently and effectively while improving public health outcomes across the continent. Africa CDC stands ready to support the immediate operationalization of the MoU.
About Africa Centres for Disease Control and Prevention (Africa CDC)
Africa CDC is a specialized public health agency of the African Union, functioning autonomously to support Member States in strengthening their health systems. The agency works to improve disease surveillance, emergency response, and disease control across Africa.
For more information, visit: http://www.africacdc.org and connect with Africa CDC on LinkedIn, Twitter, Facebook, and YouTube.
About African Medicines Regulatory Harmonization (AMRH)
The African Medicines Regulatory Harmonization (AMRH) program was established in 2009 to address challenges faced by National Medicines Regulatory Authorities (NMRAs) in Africa.
These challenges include fragmented legislative frameworks, prolonged medicine registration processes, inefficiencies, and limited technical capacity. Such regulatory weaknesses contribute to delayed access to essential medicines and increased costs. AMRH seeks to enhance regulatory efficiency and facilitate access to quality-assured medicines across the continent.
Godfred Sey/Ahotoronline.com
