By Joyce Ekeh
The National Agency for Food and Drug Administration and Control (NAFDAC) has assured Nigerians that medicines and vaccines entering the country under government-to-government agreements will be subjected to quality and safety safeguards, with products not manufactured in the United States to undergo testing by the agency.
In a press statement, the Director-General, NAFDAC, Prof. Mojisola Christianah Adeyeye said the agency would deploy its regulatory framework and technology-driven tracking system to monitor medical products supplied under the United States-Nigeria Government (USG-GoN) agreement, which is intended to provide HIV/AIDS medicines to fill the gap created by the exit of the United States Agency for International Development (USAID).
The agency stressed that the arrangement would not compromise its statutory responsibility to protect public health.
“NAFDAC retains its responsibility for Nigeria’s own decision,” the agency declared, explaining that products manufactured in the US and approved by the US Food and Drug Administration (FDA) may benefit from expedited regulatory approval under an existing regulatory-reliance framework.
However, products donated under the agreement that are not manufactured in the US will be tested by NAFDAC for quality, safety and efficacy, according to the statement.
Reliance does not mean surrender
The agency said regulatory reliance was designed to prevent unnecessary duplication and speed up access to quality-assured medicines, rather than strip Nigeria of its authority to regulate products entering the country.
Quoting the Coordinating Minister of Health and Social Welfare, Prof. Ali Pate, NAFDAC reiterated that it would continue to exercise its statutory powers over medicines, vaccines and diagnostics.
“Regulatory reliance reduces unnecessary duplication and accelerates access to quality-assured products; it does not remove NAFDAC’s authority to evaluate applications, inspect products and facilities, undertake risk-based testing, release vaccine lots and conduct post-market surveillance where required,” the statement said.
The clarification comes as the agency seeks to reassure the public that expedited approval under international regulatory arrangements will not mean abandoning Nigeria’s independent safeguards.
COVID-19 vaccines, HIV drugs under watch
NAFDAC cited its handling of COVID-19 vaccines during the pandemic as evidence of its approach to product safety, saying all COVID-19 vaccines supplied to Nigeria were tested at its Vaccine, Biologics and Medical Devices Laboratory in Yaba, Lagos, despite their safety declarations by the World Health Organisation.
It also said antiretroviral, tuberculosis and malaria drugs supplied through the Global Fund are tested annually by the agency.
The regulator maintained that these measures demonstrate its continued oversight of essential medicines and vaccines, including products supplied through international partnerships.
Technology to track every shipment
Beyond laboratory testing and regulatory approval, NAFDAC said it would deploy its GS1 technology-driven Track and Trace system to monitor the movement and distribution of medical products supplied under the USG-GoN agreement.
The agency said the same 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 added that the system is now being used to monitor non-COVID-19 vaccines and has been extended to supply chains involving narcotics, maternal health and newborn-care 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 said.
The system is intended to help the agency monitor where products are distributed within Nigeria, strengthening visibility across the supply chain.
We will not fail Nigerians
NAFDAC said it would not shirk its responsibility to safeguard public health, regardless of the origin of medicines and vaccines supplied through international agreements.
“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 declared.
The agency reiterated its commitment to protecting Nigerians through regulatory oversight, product testing where required and technology-driven monitoring of medical supplies entering and circulating within the country.
