NAFDAC To Test Non-US-Made Donated Drugs, Vaccines Under Nigeria-US Deal
The National Agency for Food and Drug Administration and Control (NAFDAC) has assured Nigerians that donated medicines and vaccines supplied under the Nigeria-United States government agreement will undergo appropriate regulatory checks, with products not manufactured in the US subject to testing for quality, safety and efficacy.
The agency also announced plans to deploy its technology-driven Track and Trace system to monitor the movement and distribution of all medical products supplied under the agreement, as the Federal Government seeks to sustain critical health interventions, particularly HIV/AIDS treatment, following the withdrawal of support from the United States Agency for International Development (USAID).
In a statement signed by its Director-General, Prof. Mojisola Christianah Adeyeye, NAFDAC explained that products manufactured in the United States and approved by the US Food and Drug Administration (FDA) could benefit from expedited regulatory consideration under its existing regulatory-reliance framework.
However, the agency stressed that the arrangement would not remove its statutory authority to regulate medicines and vaccines entering Nigeria.
“NAFDAC retains its responsibility for Nigeria’s own decision,” the agency stated, adding that donated products not manufactured in the United States would be tested to establish their quality, safety and efficacy.
The clarification comes amid efforts to ensure the continued availability of essential medical supplies under the Nigeria-US government agreement, particularly for HIV/AIDS programmes affected by changes in US development assistance.
NAFDAC explained that regulatory reliance was designed to eliminate unnecessary duplication of regulatory processes and accelerate access to quality-assured medical products without compromising Nigeria’s public health safeguards.
The agency cited the position of the Coordinating Minister of Health and Social Welfare, Prof. Ali Pate, that regulatory reliance does not strip NAFDAC of its powers to evaluate applications, inspect products and manufacturing facilities, conduct risk-based testing, release vaccine batches 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 an existing regulatory-reliance arrangement with the US FDA, under which products manufactured in the US and approved by the American regulator may receive expedited consideration.
It maintained that it would continue to exercise its statutory responsibilities over medicines, vaccines and diagnostic products, irrespective of the regulatory pathway adopted.
To reinforce its commitment to public safety, the agency 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 (WHO).
NAFDAC also disclosed that antiretroviral medicines used in HIV treatment, as well as tuberculosis and malaria drugs supplied through the Global Fund, undergo annual testing by the agency.
It said the measures demonstrated its commitment to ensuring that essential medicines and vaccines provided through international partnerships meet the required safety and quality standards before and during their use.
Beyond regulatory assessment and product testing, the agency said it would deploy the GS1 technology-driven Track and Trace system to monitor medical supplies distributed under the Nigeria-US agreement.
NAFDAC explained that the system was previously used to monitor the distribution of COVID-19 vaccines in Nigeria, with the resulting information preserved in its Traceability Information System (TIS).
It added that the technology had 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 agency noted that the technology would improve visibility across the medical supply chain, enabling it to monitor the movement and distribution of products within the country.
Reaffirming its commitment to public health, NAFDAC insisted that it would not abandon its statutory responsibility to protect Nigerians against unsafe, substandard or otherwise non-compliant 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 declared.
The agency urged Nigerians to remain assured that regulatory oversight, appropriate product testing and technology-driven supply-chain monitoring would remain central to its handling of medicines and vaccines supplied under the Nigeria-US government agreement.