Regulatory Affairs
NAFDAC Reaffirms Safety Checks for Donated Medicines Under US–Nigeria Health Agreement
NAFDAC says donated medicines and vaccines supplied under the US–Nigeria health agreement remain subject to Nigerian regulatory oversight, including risk-based testing and supply-chain monitoring, as the country seeks to sustain HIV/AIDS services.
LAGOS, 20 October 2026 – The National Agency for Food and Drug Administration and Control (NAFDAC) has reaffirmed its responsibility for ensuring the quality, safety and efficacy of medicines, vaccines and diagnostic products supplied to Nigeria under government-to-government agreements, including the health partnership with the United States.
In a press release issued on Tuesday, the agency said medical products covered by the United States Government–Government of Nigeria (USG–GoN) agreement would remain subject to appropriate regulatory oversight. The supplies are intended to support HIV/AIDS services and address gaps following the exit of the United States Agency for International Development (USAID).
NAFDAC Director-General, Prof. Mojisola Adeyeye, reiterated that the agency retains its statutory mandate to regulate medicines, vaccines and diagnostics entering the Nigerian market, regardless of the arrangements under which they are supplied.
Regulatory reliance does not remove NAFDAC’s authority
Under the regulatory-reliance framework referenced in the agreement, eligible products manufactured in the United States and approved by the US Food and Drug Administration (FDA) may qualify for expedited regulatory review.
However, NAFDAC stated that products not manufactured in the United States would undergo its quality, safety and efficacy testing. It also emphasised that regulatory reliance does not remove its authority to make regulatory decisions for Nigeria.
The agency listed product evaluation, manufacturing-facility inspections, risk-based testing, vaccine lot release and post-market surveillance, where required, among its regulatory responsibilities.
This distinction is important because reliance on another regulator’s assessment can help streamline regulatory processes without automatically transferring regulatory authority or eliminating applicable national requirements.
Track-and-trace system to monitor distribution
NAFDAC also announced plans to use its GS1 technology-driven Track and Trace system to monitor the supply chain and distribution of medical products covered by the agreement.
According to the agency, the system records product distribution through its Traceability Information System (TIS). It was previously used to monitor COVID-19 vaccines during the pandemic and has since been extended to non-COVID-19 vaccines and selected commodities, including narcotics and maternal and newborn health products.
Traceability can help regulators and supply-chain stakeholders follow the movement of medical products through distribution channels. When effectively implemented, such systems can support investigations into suspected diversion, improve visibility of product movement and strengthen accountability across the supply chain.
NAFDAC’s existing pharmaceutical traceability programme uses GS1 standards to support product identification and tracking. Its implementation has expanded beyond the initial COVID-19 vaccine work to additional medicine and public-health commodity categories.
Implications for medicine quality and public health
The agreement comes amid efforts to sustain HIV/AIDS services following changes in US-funded international development support. Ensuring access to essential medicines is important, but maintaining appropriate quality and safety safeguards remains a parallel regulatory responsibility.
For pharmacists and other healthcare professionals, the announcement reinforces the importance of obtaining medicines through authorised supply channels, maintaining appropriate storage and distribution conditions, and following applicable procedures for identifying and reporting suspected substandard or falsified products.
The announcement does not, by itself, establish that every product supplied under the agreement has undergone laboratory testing or that any particular shipment has passed regulatory checks. Those conclusions would require product-specific or shipment-specific information from the relevant authorities.
NAFDAC said it remained committed to ensuring that medical products supplied to Nigerians meet the required standards of quality, safety and efficacy.
Source: National Agency for Food and Drug Administration and Control (NAFDAC), press release dated 20 October 2026.