NAFDAC, African regulatory agencies sign MoU to speed up medicine approval

African National Regulatory Agencies (NRAs) under the World Health Organisation’s (WHO) maturity level 3, have signed a memorandum of understanding (MoU).

Announcing the development in a statement on Friday, the Africa Centre for Disease Control (CDC) said the MoU aims to create a framework that streamlines regulatory decisions to speed up the approval of medicines, vaccines and medical devices.

The Africa CDC said it would also promote collaboration on vaccine lot releases.

“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,” the statement reads.

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, and Rwanda Food and Drugs Authority (FDA).

Others are 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).

Benefits of the MoU include efficient regulatory processes, timely access to medicines, strengthened collaboration and optimised resource use.

According to the statement, the signatories commit to streamline application submission and evaluation processes to speed up 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 statement reads.

“The MoU also establishes mechanisms to ensure that authorised products and clinical trials meet internationally accepted regulatory standards.”