Some personalities at the event
The African Union Development Agency – New Partnership for Africa’s Development (AUDA-NEPAD) and the Africa Centres for Disease Control and Prevention (Africa CDC) have taken a major step in improving regulatory systems across the continent.
The newly signed Memorandum of Understanding (MoU) among Africa’s WHO Maturity Level 3 National Regulatory Authorities (NRAs) is set to enhance collaboration, streamline regulatory decisions, and facilitate faster approval of essential medical products.
The agreement is designed to create a structured framework that promotes reliance on regulatory decisions among participating agencies. This approach will expedite the approval of medicines, vaccines, and medical devices while fostering cooperation in vaccine lot release.
Additionally, the initiative is expected to bolster local pharmaceutical production, reducing dependency on imports and enhancing Africa’s healthcare sovereignty.
Below are details of the MoU as shared in a press release:
The African Union Development Agency – New Partnership for Africa’s Development (AUDA-NEPAD) and Africa Centres for Disease Control and Prevention (Africa CDC) are proud to announce the signing of a Memorandum of Understanding (MoU) among Africa’s WHO Maturity Level 3 National Regulatory Authorities (NRAs).
This agreement marks a significant milestone in strengthening regulatory systems across the continent by fostering collaboration and reliance on regulatory decisions among signatory agencies while also propelling an enabling environment for local production of medical products.
The primary objective of this MoU is to establish a structured framework for reliance on regulatory decisions to expedite the approval processes for medicines, vaccines, and medical devices well as to foster collaboration on the vaccine lot release function.
The MoU was signed by 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 Medicines Control Authority of Zimbabwe (MCAZ).
Through this agreement, the signatories commit to streamline application submission and evaluation processes to expedite regulatory processes, reduce costs, and ensure timely regulatory decision-making. This 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 meet internationally accepted regulatory standards.
Key Benefits of the MoU:
• Efficient Regulatory Processes: The MoU facilitates the sharing of assessment reports, Quality Control laboratory results, and Good Manufacturing/Clinical Practice (GMP/GCP) inspection reports among the parties, thereby reducing duplication of work and enhancing efficiency.
• Timely Access to Medicines: By leveraging shared regulatory decisions, the agreement will help accelerate access to essential medicines, vaccines, and medical devices across Africa.
• Strengthened Collaboration: The MoU fosters a cooperative environment where regulatory authorities can support one another, benefiting from each other’s scientific expertise while maintaining their independent regulatory responsibilities.
• Optimized Resource Use: Countries with limited regulatory resources can rely on stronger agencies, allowing them to enhance their regulatory capacity without compromising public health standards.
Under this framework, reliance can be unilateral, bilateral, mutual, or multilateral, allowing each authority to utilize shared regulatory data based on its national requirements while ensuring compliance with regional and international standards.
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. By fostering collaboration among National Regulatory Authorities, the MoU supports the broader continental agenda of ensuring timely access to safe and effective medical products. It also aligns with the upcoming transition toward the operationalization of the African Medicines Agency (AMA), reinforcing the need for harmonized regulatory processes to safeguard health systems of the continent.
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 re-enforces the continent’s commitment on strengthening our capabilities to locally manufacture the medical products the continent needs to respond to health challenges.”
H,E. Dr. Jean Kaseya, Director General, Africa CDC noted the signing of the MoU by the ML3 National Regulatory Authorities is a significant milestone in supporting the Africa CDC’s effort in expanding the local manufacturing of vaccines and other health commodities on the continent.
It also 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, enabling faster deployment of life-saving medical interventions during outbreaks.
In partnership with AUDA-NEPAD and AMA, Africa CDC continues to champion regulatory harmonization efforts and local manufacturing of medical products. This MoU sets a precedent for future collaborations, ultimately advancing Africa’s capacity to regulate medical products efficiently and effectively while improving health outcomes across the continent. Africa CDC stands ready to support the immediate operationalization of the MoU.