The National Agency for Food and Drug Administration and Control (NAFDAC) will test all donated medicines and vaccines not manufactured in the United States for quality, safety and efficacy under a Nigeria-US government agreement, the agency said on Tuesday.
The move aims to maintain supplies for HIV/AIDS treatment after the exit of the United States Agency for International Development (USAID). NAFDAC will also use its GS1 technology-driven Track and Trace system to monitor the distribution of all medical products supplied under the United States Government-Nigeria Government (USG-GoN) agreement.
In a statement signed by Director-General Prof. Mojisola Christianah Adeyeye, the agency said US-manufactured products already approved by the US Food and Drug Administration could receive expedited approval under NAFDAC’s existing regulatory-reliance framework. Products made outside the United States will still undergo full testing.
“NAFDAC retains its responsibility for Nigeria’s own decision,” the agency stated. It stressed that the arrangement does not remove Nigeria’s authority to regulate medicines and vaccines entering the country.
The Coordinating Minister of Health and Social Welfare, Prof. Ali Pate, has previously noted that regulatory reliance does not prevent NAFDAC from evaluating applications, inspecting products and manufacturing facilities, conducting risk-based testing, releasing vaccine lots or carrying out post-market surveillance.
NAFDAC said the USG-GoN memorandum of understanding refers to its existing reliance arrangement with the US FDA. It will continue to exercise its statutory responsibility over medicines, vaccines and diagnostics regardless of the pathway used.
The agency pointed to past practice as evidence of its approach. All COVID-19 vaccines supplied to Nigeria were tested at its Vaccine, Biologics and Medical Devices Laboratory in Yaba, Lagos, even after the World Health Organisation declared them safe.
Antiretroviral, tuberculosis and malaria drugs supplied through the Global Fund are also tested annually.
The same Track and Trace system used for COVID-19 vaccines, and later extended to non-COVID-19 vaccines, narcotics, maternal health supplies and newborn-care commodities, will cover all products arriving under the USG-GoN agreement. Information from the system is stored in NAFDAC’s Traceability Information System.
“NAFDAC will use the same GS1 technology-driven Track and Trace system to monitor ALL medical products that come into the country under the USG-GoN Agreement,” the statement said.
The agency reaffirmed that it would not abandon its duty to protect Nigerians from unsafe or substandard medical products and urged the public to have confidence in its regulatory oversight, testing and distribution monitoring.
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