US-Nigeria Health Deal: NAFDAC Vows To Test, Track Medical Supplies

The National Agency for Food and Drug Administration and Control (NAFDAC) has assured Nigerians that medicines and vaccines supplied under bilateral agreements with other countries will undergo quality and safety checks, with their distribution monitored through a technology-driven tracking system.

The agency said the United States-Nigeria government-backed medical products under the health cooperation agreement are intended to address shortages of HIV/AIDS commodities following the exit of the United States Agency for International Development (USAID).

The Director-General of NAFDAC, Prof. Mojisola Adeyeye, in a statement on Tuesday, said it would retain its statutory responsibility for regulating medicines, vaccines and diagnostic products entering the country, including those supplied under the US-Nigeria government agreement.

She explained that products manufactured in the United States and approved by the US Food and Drug Administration (FDA) could benefit from expedited regulatory approval under its existing regulatory reliance framework, given the stringent standards applied by the American regulator.

However, she stressed that products not manufactured in the United States would be subjected to quality, safety and efficacy tests by NAFDAC.

“The USG-GoN MoU refers to NAFDAC’s existing regulatory-reliance framework with US FDA where products manufactured in the USA, approved through the very stringent US FDA regulations are given expedited approval because of the stringency given to the process by US FDA.

“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,” she said.

Adeyeye added that regulatory reliance does not remove its authority to evaluate applications, inspect products and manufacturing facilities, conduct risk-based testing, release vaccine batches where required and carry out post-market surveillance.

According to her, NAFDAC had previously subjected all COVID-19 vaccines supplied to Nigeria during the pandemic to testing at its Vaccine, Biologics and Medical Devices Laboratory in Yaba, Lagos, despite their safety declarations by the World Health Organisation.

She also disclosed that antiretroviral, tuberculosis and malaria medicines supplied through the Global Fund are tested annually by the agency.

On the monitoring of products after their entry into the country, the DG said NAFDAC would deploy its GS1 technology-driven Track and Trace system to monitor the distribution of all medical products supplied under the US-Nigeria agreement.

She said the system was used to monitor the distribution of COVID-19 vaccines during the pandemic, with the records stored in its Traceability Information System (TIS).

Adeyeye added that the same technology was now being used to monitor non-COVID-19 vaccines, as well as the supply chains for narcotics, maternal health commodities and newborn care products.

NAFDAC said the system would help it monitor the movement and distribution of medical products throughout the supply chain.

The agency reiterated its commitment to safeguarding public health, stressing that it would continue to discharge its regulatory responsibilities under the law.