Landmark agreement among Africa’s leading National Medicines Regulatory Authorities to foster collaboration

Cairo, Egypt, 4 February 2025: The Africa Centres for Disease Control and Prevention (Africa CDC) and African Union Development Agency – New Partnership for Africa’s Development (AUDA-NEPAD) are proud to announce the signing of a Memorandum of Understanding (MoU) among Africa’s WHO Maturity Level 3 National Regulatory Authorities (NRAs). These agencies have established robust systems to ensure the safety, efficacy and quality of medical products in line with international regulatory standards.

The 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 creating an enabling environment for the local production of medical products. It aims to create a framework that streamlines regulatory decisions to speed up the approval of medicines, vaccines and medical devices, while promoting collaboration on vaccine lot releases.

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 the assessment reports generated by the participating authorities. The MoU also establishes mechanisms to ensure that authorised 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 of 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. 
• Optimised 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 utilise shared regulatory data based on its national requirements while ensuring compliance with regional and international standards.

A Milestone for AUDA-NEPAD’s AMRH, Africa CDC, and the Future of AMA

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 NRAs, 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 operationalisation of the African Medicines Agency (AMA), reinforcing the need for harmonised regulatory processes to safeguard health systems on the continent.

H.E. Nardos Bekele-Thomas, CEO of AUDA-NEPAD emphasised 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, the Director General of Africa CDC, noted the signing of the MoU by the ML3 NRAs is a significant milestone in supporting the Africa CDC’s efforts in expanding the local manufacturing of vaccines and other health commodities on the continent. “The 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, enabling faster deployment of life-saving medical interventions during outbreaks.”

In partnership with AUDA-NEPAD and AMA, Africa CDC continues to champion regulatory harmonisation 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 operationalisation of the MoU.

Note to reader: This press release/news item was originally published by the Africa CDC – Centres for Disease Control and Prevention on 04 February 2025 – https://africacdc.org/news-item/landmark-agreement-among-africas-leading-national-medicines-regulatory-authorities-to-foster-collaboration/