Africa’s Leading Medicines Regulatory Authorities Sign MoU to Foster Reliance

Cairo: 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), including 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 and Medical Devices Authority, and Medicines Control Authority of Zimbabwe. According to Ghana News Agency, the AUDA-NEPAD and Africa Centres for Disease Control and Prevention announced this development in a joint release after their meeting in Cairo, Egypt. The agreement aims to foster collaboration and reliance on regulatory decisions among signatory agencies, creating an enabling environment for the local production of medical products. The primary objective of the MoU is to establish a structured framework for reliance on regulatory decisions to expedite the approval processes for medicines, vaccines, and medical devices. It also aims 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 agreement will be achieved through information sharing, work-sharing, and reliance on 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.