The National Agency for Food and Drug Administration and Control (NAFDAC) has announced that donated medicines and vaccines not manufactured in the United States will undergo quality, safety and efficacy testing under the Nigeria-United States government health agreement.
The agency also said it would deploy its technology-driven Track and Trace system to monitor the distribution of medical products supplied under the agreement, amid efforts to sustain HIV/AIDS treatment programmes following the withdrawal of support from the United States Agency for International Development (USAID).
In a statement signed by its Director-General, Professor Mojisola Christianah Adeyeye, NAFDAC explained that medicines and vaccines manufactured in the US and approved by the US Food and Drug Administration (FDA) could receive expedited regulatory consideration under Nigeria’s existing regulatory-reliance framework, The News Edition reports.
However, the agency stressed that the arrangement would not undermine Nigeria’s authority to regulate medical products entering the country.
“NAFDAC retains its responsibility for Nigeria’s own decision,” the agency stated, adding that products not manufactured in the United States would be tested for quality, safety and efficacy.
NAFDAC Retains Regulatory Authority Under Nigeria-US Agreement
NAFDAC explained that regulatory reliance is intended to reduce unnecessary duplication of regulatory procedures and speed up access to quality-assured medicines and vaccines without compromising public safety.
The agency cited the position of the Coordinating Minister of Health and Social Welfare, Professor Ali Pate, who said the arrangement does not remove NAFDAC’s authority to evaluate applications, inspect products and manufacturing facilities, conduct risk-based testing, release vaccine lots and carry out post-market surveillance where necessary.
According to NAFDAC, the memorandum of understanding between the United States Government and the Nigerian Government refers to the agency’s existing regulatory-reliance arrangement with the US FDA.
Under the framework, products manufactured in the US and approved by the American regulator may qualify for faster consideration. NAFDAC maintained that it would continue to exercise its statutory responsibilities over medicines, vaccines and diagnostic products, regardless of the regulatory pathway applied.
Agency Cites COVID-19 Vaccine Testing as Safety Measure
To demonstrate its commitment to protecting public health, NAFDAC recalled that COVID-19 vaccines supplied to Nigeria during the pandemic were tested at its Vaccine, Biologics and Medical Devices Laboratory in Yaba, Lagos, despite having been declared safe by the World Health Organisation.
The agency also disclosed that antiretroviral medicines used in HIV treatment, as well as tuberculosis and malaria drugs supplied through the Global Fund, undergo annual testing.
NAFDAC said these measures reflected its commitment to ensuring that essential medicines and vaccines received through international partnerships meet the required standards.
NAFDAC to Track Medical Supplies Under US-Nigeria Deal
Beyond regulatory assessment and product testing, NAFDAC said it would use the GS1 technology-driven Track and Trace system to monitor the movement and distribution of all medical products supplied under the Nigeria-US agreement.
The agency explained that it had previously used the system to monitor COVID-19 vaccine distribution, with the relevant information preserved in its Traceability Information System (TIS).
According to NAFDAC, the system has since been extended to cover non-COVID-19 vaccines, narcotics, maternal health supplies and newborn-care commodities.
“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 system is designed to improve visibility across the medical supply chain and help the agency monitor how products are distributed within Nigeria.
NAFDAC Reaffirms Commitment to Public Health
The agency reiterated that it would not abandon its statutory responsibility to protect Nigerians from unsafe, substandard or otherwise unsuitable medical products.
“As the Agency with the mandate to safeguard the health of Nigerians, NAFDAC will NOT fail to carry out this responsibility as enshrined in the mandate,” the statement added.
NAFDAC urged Nigerians to be assured that regulatory oversight, appropriate product testing and technology-driven monitoring would remain central to its handling of medical supplies entering the country under the Nigeria-US government agreement.