Africa’s leading medicines regulatory authorities sign MoU to foster reliance

The African Union Development Agency – New Partnership for Africa’s Development (AUDA-NEPAD) and Africa Centres for Disease Control and Prevention have signed a Memorandum of Understanding (MoU) marking a significant milestone in strengthening regulatory systems across the continent.

The agreement was signed among Africa’s WHO Maturity Level Three National Regulatory Authorities (NRAs).

These include Ghana’s Food and Drugs Authority (FDA), the National Agency for Food and Drug Administration and Control of Nigeria, and Rwanda’s Food and Drugs Authority, who signed on behalf of their respective countries.  

The rest are Senegalese Pharmaceutical Regulatory Agency, South African Health Products Regulatory Authority, Tanzania Medicines & Medical Devices Authority, and Medicines Control Authority of Zimbabwe.

The AUDA-NEPAD and Africa Africa Centres for Disease Control and Prevention made this known in a joint release copied to the Ghana News Agency on Friday after their meeting in Cairo, Egypt on February 4, 2025.

The release said the agreement marked a significant milestone in strengthening regulatory systems across the continent by fostering collaboration and reliance on regulatory decisions among signatory agencies while propelling an enabling environment for local production of medical products.

The primary objective of the MoU was to establish a structured framework for reliance on regulatory decisions to expedite the approval processes for medicines, vaccines, and medical devices to foster collaboration on the vaccine lot release function.

“Through this agreement, the signatories commit to streamlining application submission and evaluation processes to expedite regulatory processes, reduce costs, and ensure timely regulatory decision-making,” the release said.

“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 would also establish mechanisms to ensure that authorised products and clinical trials meet internationally accepted regulatory standards.

Source: GNA

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