By BONIFACE AKARAH

The National Agency for Food and Drug Administration and Control (NAFDAC) has assured Nigerians that medicines and vaccines supplied under the United States-Nigeria government agreement will undergo appropriate quality and safety checks, with the agency retaining regulatory authority over products entering the country.

The agency gave the assurance in a statement issued by its management and signed by its Director-General, Prof. Mojisola Christianah Adeyeye, explaining that the US Government-Nigerian Government (USG-GoN) medical products were intended to address gaps in HIV/AIDS treatment supplies following the exit of the United States Agency for International Development (USAID).

NAFDAC said the arrangement would not prevent it from exercising its statutory responsibility to protect public health, stressing that regulatory reliance on approvals from trusted foreign regulators does not amount to surrendering its authority.

“As stated by the Coordinating Minister of Health and Social Welfare, Prof. Ali Pate, NAFDAC continues to exercise its statutory responsibility for medicines, vaccines and diagnostics,” the statement said.

The agency explained that regulatory reliance could reduce unnecessary duplication and accelerate access to quality-assured products, while preserving its powers to evaluate applications, inspect products and facilities, conduct risk-based testing, release vaccine lots and undertake post-market surveillance where necessary.

NAFDAC said its existing regulatory-reliance framework with the United States Food and Drug Administration (US FDA) allows expedited approval for products manufactured in the United States and approved under the regulator’s stringent requirements.

However, the agency clarified that products donated under the agreement but manufactured outside the United States 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,” the statement said, adding that the agency retained responsibility for making regulatory decisions for Nigeria.

To support its assurances, NAFDAC cited its record of testing vaccines and medicines supplied to the country through international arrangements.

It said all COVID-19 vaccines administered in Nigeria during the pandemic were tested at its Vaccine, Biologics and Medical Devices Laboratory in Yaba, Lagos, despite their prior safety declarations by the World Health Organization (WHO).

The agency also disclosed that it tests antiretroviral, tuberculosis and malaria medicines supplied through the Global Fund annually.

NAFDAC further highlighted its use of GS1 technology-driven track-and-trace systems to monitor the distribution of medical products within Nigeria.

According to the agency, 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). It said the same technology was now being used to track non-COVID-19 vaccines.

“The Agency has started using TIS to monitor the supply chain or distribution of narcotics, maternal and newborn child commodities,” the statement said.

NAFDAC added that it would extend the use of the system to monitor all medical products supplied under the USG-GoN agreement, enabling the agency to follow their distribution within the country.

Reaffirming its commitment to public health, the agency said it would continue to discharge its regulatory responsibilities under its statutory 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 statement added.

The agency reiterated its public health commitment with its declaration: “NAFDAC — SAFEGUARDING the HEALTH of Nigerians.”