NAFDAC won’t compromise on medicine safety under US-Nigeria deal — DG

The Director-General of the National Agency for Food and Drug Administration and Control (NAFDAC), Prof. Mojisola Christianah Adeyeye, has assured Nigerians that the agency will maintain strict regulatory oversight of medicines and vaccines supplied under the United States Government–Government of Nigeria (USG-GoN) agreement.

Adeyeye said the products are intended to support HIV/AIDS treatment and bridge the supply gap created by the exit of the United States Agency for International Development (USAID).

She explained that the agreement builds on NAFDAC’s existing regulatory-reliance framework with the United States Food and Drug Administration (US FDA), under which eligible products manufactured in the United States and approved by the regulator may qualify for expedited review, subject to applicable Nigerian requirements.

The NAFDAC boss stressed that regulatory reliance does not diminish the agency’s statutory authority to evaluate applications, inspect products and manufacturing facilities, conduct risk-based testing, and undertake post-market surveillance.

Citing the agency’s track record, she said all COVID-19 vaccines supplied to Nigeria during the pandemic were tested at NAFDAC’s Vaccine, Biologics and Medical Devices Laboratory in Yaba, Lagos, despite prior safety assessments by the World Health Organization (WHO). She added that the agency conducts annual testing of antiretroviral, tuberculosis, and malaria medicines supplied through the Global Fund.

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Adeyeye further stated that products covered by the USG-GoN agreement that are not manufactured in the United States would undergo NAFDAC testing to establish their quality, safety, and efficacy, as applicable. She emphasised that Nigeria retains the authority to make its own regulatory decisions on medical products entering the country.

The Director-General also disclosed that NAFDAC would deploy its GS1 technology-driven Track and Trace system to monitor all medical products supplied under the agreement.

She said the system, previously used to track the distribution of COVID-19 vaccines, now supports the monitoring of other vaccines, narcotics, and maternal, newborn, and child health commodities through the NAFDAC Traceability Information System (TIS).

Adeyeye reaffirmed that NAFDAC would continue to facilitate access to essential medicines while upholding its statutory responsibility to safeguard public health.