By Seun Ibiyemi
The National Agency for Food and Drug Administration and Control (NAFDAC) has assured Nigerians that medicines and vaccines supplied under the United States-Nigerian Government (USG-GoN) agreement will be subjected to appropriate regulatory oversight to ensure their quality, safety and efficacy.
The agency said the USG-GoN medical products, which are intended to support HIV/AIDS programmes, are being supplied to fill the gap created by the exit of the United States Agency for International Development (USAID).
In a statement issued by its management and signed by the Director-General, Prof. Mojisola Christianah Adeyeye, NAFDAC maintained that it would not compromise its statutory responsibility to protect the health of Nigerians.
The agency explained that the memorandum of understanding between the United States and Nigerian governments refers to its existing regulatory reliance framework with the United States Food and Drug Administration (US FDA).
Under the framework, products manufactured in the United States and approved by the US FDA may benefit from expedited regulatory approval because of the rigour of the American regulator’s assessment process.
However, NAFDAC clarified that products donated under the agreement that are not manufactured in the United States would be tested by the agency to establish their quality, safety and efficacy.
It stressed that regulatory reliance does not remove its authority to evaluate applications, inspect products and manufacturing facilities, conduct risk-based testing, release vaccine batches where required and undertake post-market surveillance.
The agency said the framework was designed to reduce unnecessary duplication of regulatory processes and accelerate access to quality-assured medical products without undermining Nigeria’s regulatory authority.
NAFDAC cited its experience during the COVID-19 pandemic as evidence of its commitment to independent quality assurance, noting that all COVID-19 vaccines supplied to Nigeria during the period were tested at its Vaccine, Biologics and Medical Devices Laboratory in Yaba, Lagos, despite their safety declarations by the World Health Organisation.
It also disclosed that antiretroviral, tuberculosis and malaria drugs supplied through the Global Fund undergo annual testing by the agency.
On the monitoring of medical products, NAFDAC said it had deployed a GS1 technology-driven Track and Trace system to monitor the distribution of COVID-19 vaccines brought into the country during the pandemic.
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According to the agency, the distribution data are stored in its Traceability Information System (TIS), which is now also being used to monitor non-COVID-19 vaccines.
The system has further been extended to track the supply chains and distribution of narcotics, maternal health products and commodities for newborns and children.
NAFDAC said it would deploy the same technology to monitor all medical products entering Nigeria under the USG-GoN agreement, strengthening supply-chain visibility and helping the agency track the movement of products.
The agency reiterated that protecting public health remains central to its mandate and pledged to continue enforcing the regulatory requirements governing medicines, vaccines and diagnostic products entering the Nigerian market.
“NAFDAC will NOT fail to carry out this responsibility as enshrined in the mandate,” the statement said.
The assurance comes as the Federal Government and its United States counterpart pursue arrangements to sustain access to HIV/AIDS-related medical products following the withdrawal of USAID support.
NAFDAC said its regulatory oversight would remain in place to ensure that products supplied under the arrangement meet the applicable requirements for quality, safety and efficacy.
