NAFDAC to test non-US-made donated drugs, vaccines under Nigeria-US deal

NAFDAC announced that donated medicines and vaccines not manufactured in the United States will undergo testing before use. The checks will assess quality, safety and efficacy. This matters because the supplies are expected to support HIV/AIDS treatment after USAID withdrew its support.

US-made products approved by the US Food and Drug Administration may receive expedited consideration through NAFDAC’s regulatory-reliance framework. Products made elsewhere do not receive that stated pathway, so NAFDAC will test them directly. The agency will also apply its GS1 Track and Trace system to monitor distribution.

This arrangement does not remove Nigeria’s regulatory authority. NAFDAC said it will retain responsibility for decisions, conduct risk-based testing where needed and monitor products after they reach the market. It described the approach as a way to avoid duplication while protecting Nigerians from unsafe or substandard supplies.

Regulatory reliance means NAFDAC can use the work of a trusted foreign regulator instead of repeating every assessment from the beginning. The goal is to reduce unnecessary duplication and speed access to quality-assured medicines and vaccines. It is an efficiency measure, not a surrender of regulatory control.

Under the arrangement described, US-made products approved by the US FDA may receive expedited consideration. NAFDAC can still evaluate applications, inspect products and manufacturing facilities, conduct risk-based testing, release vaccine lots and carry out post-market surveillance. These powers allow Nigeria to make its own regulatory decision.

The current agreement therefore combines reliance with national oversight. NAFDAC said it retains responsibility for medicines, vaccines and diagnostics entering Nigeria, regardless of the pathway used. Products not manufactured in the United States will undergo testing for quality, safety and efficacy, while all supplies will be tracked through the distribution system.

The difference rests on the regulatory pathway available to each product. US-made medicines and vaccines approved by the US FDA may receive expedited consideration because the American agency applies stringent regulatory processes. This can help avoid repeating work that has already been completed.

NAFDAC’s statement gives non-US-manufactured products a different treatment. They will be tested for quality, safety and efficacy. The agency did not say that every such product will automatically be rejected or delayed, but it clearly committed to testing them before they are accepted through the agreement.

Expedited consideration does not mean automatic approval. NAFDAC said it will make Nigeria’s own decision and retain powers including application review, facility inspection, risk-based testing, vaccine-lot release and post-market surveillance. The approach aims to balance faster access with protection against unsafe or substandard products.

The GS1 Track and Trace system is broad because NAFDAC plans to use it for all medical products supplied under the United States Government-Nigeria Government agreement. It is designed to show where products move through the supply chain and how they are distributed within Nigeria.

NAFDAC first used the system to monitor COVID-19 vaccine distribution. The resulting information was preserved in its Traceability Information System, known as TIS. The agency later extended the system beyond COVID-19 vaccines to non-COVID-19 vaccines, narcotics, maternal health supplies and newborn-care commodities.

The system will now cover every medical product arriving through this agreement. That creates a technology-based record of movement and distribution, alongside product testing and regulatory review. NAFDAC said the system will improve supply-chain visibility and help it monitor products after they enter the country.

Testing can reduce the risk that donated medicines or vaccines fail to meet required standards. NAFDAC will assess non-US-manufactured products for quality, safety and efficacy, while retaining oversight of products approved through reliance. This matters as government-backed supplies are expected to help sustain HIV/AIDS interventions after USAID support ended.

Tracking adds a supply-chain safeguard. NAFDAC’s GS1 system records and monitors the movement and distribution of medical products across the country. The agency used it for COVID-19 vaccines and stores information in its Traceability Information System. It has also extended the system to several other medical categories.

Together, testing and tracking can support safer and more visible delivery. NAFDAC can identify how products move and maintain regulatory checks while supplies reach programmes. The article does not provide distribution numbers, but it says the measures are intended to bridge treatment-supply gaps without weakening safeguards.

NAFDAC said it has applied national oversight even when products had already received international assurance. During the COVID-19 pandemic, every vaccine supplied to Nigeria was tested at NAFDAC’s Vaccine, Biologics and Medical Devices Laboratory in Yaba, Lagos. This testing took place despite WHO declarations that the vaccines were safe.

The agency also disclosed annual testing of antiretroviral, tuberculosis and malaria medicines supplied through the Global Fund. These examples show the types of checks NAFDAC uses for products arriving through international partnerships. The stated purpose is to confirm that essential medicines and vaccines meet required standards.

NAFDAC presented this history as evidence that it will continue exercising its statutory responsibility under the Nigeria-US agreement. The agency said testing, approval and distribution monitoring will remain central. It also said it will undertake post-market surveillance where necessary, rather than treating outside approval as the end of oversight.

Nigeria needs its own regulator because NAFDAC is legally responsible for medicines, vaccines and diagnostics entering the country. Approval by a foreign agency or WHO provides important assurance, but NAFDAC said it must still make Nigeria’s own decision. Its role includes protecting Nigerians from unsafe or substandard medical products.

The agency’s safeguards include evaluating applications, inspecting products and manufacturing facilities, conducting risk-based testing, releasing vaccine lots and carrying out post-market surveillance. It also tests non-US-manufactured products for quality, safety and efficacy. Track and Trace adds oversight of movement and distribution after products enter Nigeria.

This national role also supports accountability within Nigeria’s supply chain. NAFDAC tested all COVID-19 vaccines supplied during the pandemic despite WHO safety declarations, and annually tests Global Fund medicines for HIV, tuberculosis and malaria. The agency says regulatory reliance should speed access, not weaken these protections.