• Deploys track-and-trace technology to monitor distribution of medicines and vaccines nationwide
Sunday Ehigiator
The National Agency for Food and Drug Administration and Control (NAFDAC) has assured Nigerians that medical products supplied under agreements between the Nigerian and United States governments will undergo appropriate regulatory checks, with their distribution monitored through a technology-driven tracking system.
The agency said the United States-Nigeria governments (USG-GoN) medical products were intended to address gaps in HIV/AIDS treatment created by the exit of the United States Agency for International Development (USAID).
In a statement yesterday, signed by its Director General, Prof. Mojisola Adeyeye, NAFDAC said it retained its statutory responsibility for regulating medicines, vaccines and diagnostic products entering Nigeria, stressing that regulatory cooperation with foreign agencies would not compromise its mandate.
“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 agency said.
NAFDAC explained that the memorandum of understanding between the US and Nigerian governments referred to its existing regulatory-reliance framework with the US Food and Drug Administration (FDA), under which products manufactured in the United States and approved by the regulator could benefit from expedited approval.
The agency, however, clarified that products not manufactured in the US would be tested by NAFDAC for quality, safety and efficacy.
“If the products donated are not manufactured in the USA, all of the products will be tested for quality, safety and efficacy by NAFDAC. That is, NAFDAC retains its responsibility for Nigeria’s own decision.”
According to the agency, regulatory reliance reduces unnecessary duplication and accelerates access to quality-assured products without removing its authority to evaluate applications, inspect products and facilities, conduct risk-based testing, release vaccine lots and undertake post-market surveillance where necessary.
NAFDAC cited its regulatory activities during the COVID-19 pandemic as evidence of its commitment to protecting public health.
“ALL COVID-19 vaccines given to Nigeria during the pandemic were tested at our Yaba Vaccine, Biologics and Medical Devices laboratory in Yaba despite the fact they have been declared safe by the World Health Organization,” it said.
The agency also disclosed that all antiretroviral, tuberculosis and malaria drugs supplied through the Global Fund were tested annually.
On monitoring the distribution of medical products, NAFDAC said it had deployed the GS1 technology-driven Track and Trace system to monitor the movement of COVID-19 vaccines distributed across Nigeria during the pandemic.
It explained that the distribution records were maintained in its Traceability Information System (TIS), which was now being used to monitor non-COVID-19 vaccines.
The agency added that it had started using the system to monitor the supply chain and distribution of narcotics, as well as maternal, newborn and child health 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 added.
The agency said the system would enable it to monitor the distribution of medical products under the agreement and reinforce oversight of their movement through the country’s supply chain.
NAFDAC reiterated its commitment to ensuring that medicines and vaccines entering Nigeria meet applicable regulatory requirements, regardless of the arrangements under which they are supplied.