…. Deploys tracking technology to monitor medical supplies, assures Nigerians of safety checks
By Chioma Obinna
The National Agency for Food and Drug Administration and Control (NAFDAC) has said all donated medicines and vaccines under the Nigeria-United States government agreement that are not manufactured in the US will undergo testing for quality, safety and efficacy, amid efforts to bridge the gap in HIV/AIDS treatment supplies following the exit of the United States Agency for International Development (USAID).
The agency, in a press statementsigned by its Director-General, Prof. Mojisola Christianah Adeyeye, said it would also deploy its technology-driven Track and Trace system to monitor the distribution of all medical products supplied under the United States Government-Nigeria Government (USG-GoN) agreement.
NAFDAC explained that US-manufactured products approved by the US Food and Drug Administration, FDA, could benefit from expedited approval under its existing regulatory-reliance framework, owing to the stringent regulatory processes applied by the American agency.
It, however, stressed that the arrangement would not strip Nigeria of its authority to regulate medicines and vaccines 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.
The clarification comes as the Nigerian government-backed medical supplies are expected to help sustain HIV/AIDS interventions following the withdrawal of USAID support.
NAFDAC said regulatory reliance was intended to reduce unnecessary duplication and accelerate access to quality-assured medical products, not to weaken the country’s regulatory safeguards.
The agency cited the position of the Coordinating Minister of Health and Social Welfare, Prof. Ali Pate, that regulatory reliance does not remove NAFDAC’s authority to evaluate applications, inspect products and manufacturing facilities, conduct risk-based testing, release vaccine lots and undertake post-market surveillance where necessary.
According to the agency, the USG-GoN memorandum of understanding refers to its existing regulatory-reliance arrangement with the US FDA, under which products manufactured in the US and approved by the regulator may receive expedited consideration.
NAFDAC maintained that it would continue to exercise its statutory responsibility over medicines, vaccines and diagnostics, regardless of the regulatory pathway applied.
To demonstrate its commitment to safety, the agency recalled that all 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.
It also disclosed that antiretroviral, tuberculosis and malaria drugs supplied through the Global Fund are tested annually by NAFDAC.
The agency said these measures reflected its continued commitment to ensuring that essential medicines and vaccines supplied through international partnerships meet the required standards.
Beyond product testing and regulatory approval, NAFDAC said it would use the GS1 technology-driven Track and Trace system to monitor the movement and distribution of medical products supplied under the Nigeria-US agreement.
The agency explained that the system was used to monitor the distribution of COVID-19 vaccines during the pandemic, with the information preserved in its Traceability Information System, TIS.
It added that the system had since been extended to 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 technology is intended to improve visibility across the medical supply chain and enable the agency to monitor the distribution of products within the country.
Reaffirming its commitment to public health, NAFDAC said it would not abdicate its statutory duty to protect Nigerians from unsafe or substandard 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 the public to be assured that regulatory oversight, appropriate product testing and technology-driven distribution monitoring would remain central to its handling of medical products entering the country under the USG-GoN agreement.
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