The National Agency for Food and Drug Administration and Control has assured Nigerians that medical products supplied under agreements between the United States and Nigerian governments will remain subject to national regulatory oversight.
NAFDAC Director-General Mojisola Adeyeye said the agency would apply its established procedures to medicines, vaccines and diagnostic products intended to help address gaps in HIV/AIDS treatment following changes to US development assistance.
The agency explained that its regulatory-reliance arrangement with the US Food and Drug Administration may permit expedited assessment of certain US-manufactured, FDA-approved products. It stressed, however, that reliance on another regulator does not transfer Nigeria’s final decision-making authority.
According to NAFDAC, donated products manufactured outside the United States would undergo its testing procedures for quality, safety and efficacy. The agency also cited its experience with vaccine assessment and testing of medicines supplied through international health programmes.
NAFDAC said it would use a GS1-based track-and-trace system to monitor products supplied under the bilateral arrangement. The technology, previously used to follow vaccine distribution, is intended to improve visibility across the medical supply chain.
The agency maintained that faster access to essential medical supplies must be accompanied by appropriate testing, monitoring and post-market surveillance.
