The National Agency for Food and Drug Administration and Control (NAFDAC) says it will independently test medical products supplied under Nigeria’s $5.1 billion health agreement with the United States if they are donated and manufactured outside the US.
The agency also said it would deploy its Track and Trace system to monitor the distribution of all medical products supplied under the agreement.
The products are intended to address gaps in HIV/AIDS services following the exit of the United States Agency for International Development (USAID).
NAFDAC Director-General, Prof. Mojisola Adeyeye, said in a statement on Tuesday that the agency retained its statutory authority to regulate medicines, vaccines and diagnostic products entering Nigeria, regardless of agreements with other countries.
Her statement comes amid scrutiny of the health partnership over provisions on health data sharing, biological specimens and Nigeria’s regulatory oversight.
The Federal Government announced in December 2025 that the five-year agreement, covering April 2026 to December 2030, would involve nearly $2.1 billion in US health assistance and about $3 billion in additional domestic spending by Nigeria. The partnership covers HIV/AIDS, tuberculosis, malaria, polio, maternal and child health, disease surveillance and laboratory services.
Daily Trust reported that medical experts had questioned provisions allowing the US to continue using specimens and related data shared by Nigeria even if the agreement is terminated. The report also raised concerns about the agreement’s data-sharing requirements, although the Federal Government has defended the partnership as a means of strengthening health security and expanding access to essential medical services.
The controversy intensified after a viral claim alleged that the agreement barred NAFDAC from inspecting medical products supplied under the deal.
NAFDAC said its regulatory reliance framework allows it to expedite approvals for products manufactured in the US and approved by the US Food and Drug Administration (FDA), citing the rigour of the American regulator’s approval process.
However, the agency said donated products manufactured outside the US would undergo its own tests to establish their quality, safety and efficacy.
It added that the arrangement did not remove its authority to evaluate applications, inspect products and manufacturing facilities, conduct risk-based testing, release vaccine batches and carry out post-market surveillance where necessary.
The agency said the approach was consistent with the position of the Coordinating Minister of Health and Social Welfare, Prof. Muhammad Pate, that regulatory reliance could reduce unnecessary duplication and speed up acc
