NAFDAC Assures Nigerians of Safety of US-Supported Medicines, Vaccines

The National Agency for Food and Drug Administration and Control (NAFDAC) has assured Nigerians that all government-backed medicines and vaccines entering the country are subjected to appropriate quality, safety and efficacy checks under existing regulatory arrangements.

The agency said the assurance covers medical products supplied under the United States-Nigeria Government (USG-GoN) agreement, particularly medicines for the treatment of HIV/AIDS intended to address supply gaps following the exit of the United States Agency for International Development (USAID).

In a press statement issued on tuesday and signed by its Director-General, Professor Mojisola Adeyeye, NAFDAC explained that regulatory reliance on approvals by recognised foreign agencies does not remove its statutory authority to protect Nigerians from unsafe or substandard medical products.

According to the agency, the agreement builds on its existing regulatory-reliance framework with the United States Food and Drug Administration (US FDA), under which products manufactured in the United States and approved through the country’s stringent regulatory system may benefit from expedited approval in Nigeria.

NAFDAC, however, stressed that products donated under the agreement that are not manufactured in the United States would undergo quality, safety, and efficacy testing by the agency.

It emphasised that Nigeria retains the final regulatory responsibility for deciding whether medical products are suitable for use in the country.

The agency cited its previous regulatory interventions as evidence of its commitment to protecting public health, noting 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.

NAFDAC also disclosed that antiretroviral, tuberculosis, and malaria medicines supplied through the Global Fund are tested annually to ensure they meet the required standards.

The agency further explained that it deploys GS1 technology-driven track-and-trace systems to monitor the distribution of medical products and strengthen accountability across the supply chain.

It said the technology was used to monitor the distribution of COVID-19 vaccines during the pandemic, with relevant information captured in the NAFDAC Traceability Information System (TIS).

According to the agency, the same system is now being deployed to monitor non-COVID-19 vaccines, while its application has been extended to the supply chains for narcotics and maternal and newborn health commodities

NAFDAC stated that it would also deploy the technology to track all medical products supplied under the USG-GoN agreement, enabling the agency to monitor their movement and distribution within Nigeria.

The agency reiterated that regulatory reliance is designed to reduce unnecessary duplication of assessments and accelerate access to quality-assured medical products without compromising its oversight responsibilities.

It added that its regulatory functions include evaluating applications, inspecting products and manufacturing facilities, conducting risk-based testing, releasing vaccine lots where required, and carrying out post-market surveillance.

The agency said it would continue to discharge its statutory mandate to safeguard the health of Nigerians and ensure that medical products distributed in the country meet the required standards.