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The National Agency for Food and Drug Administration and Control (NAFDAC) has assured Nigerians that medicines and vaccines supplied to the country under relevant international agreements will be subjected to appropriate quality, safety and efficacy checks to protect public health.
The agency said it would also deploy its technology-driven track-and-trace system to monitor the distribution of medical products supplied under the United States Government-Nigerian Government (USG-GoN) agreement.
In a statement issued on Tuesday, October 20, NAFDAC explained that the USG-GoN medical products were intended to address gaps in the supply of HIV/AIDS medicines following the exit of the United States Agency for International Development (USAID).
The agency stressed that regulatory reliance on approvals by recognised foreign regulators would not undermine its statutory authority to protect Nigerians against substandard or unsafe medical products.
According to NAFDAC, products manufactured in the United States and approved by the US Food and Drug Administration (FDA) may benefit from expedited regulatory procedures under its existing regulatory-reliance framework.
However, the agency clarified that products not manufactured in the United States would undergo quality, safety and efficacy assessments by NAFDAC.
It added that the arrangement did not remove its responsibility to evaluate applications, inspect products and manufacturing facilities, conduct risk-based testing, release vaccine batches where required and carry out post-market surveillance.
The Director-General of NAFDAC, Prof. Mojisola Christianah Adeyeye, said the agency remained committed to ensuring that medical products entering Nigeria met the required standards.
To demonstrate its commitment, NAFDAC recalled 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 their safety status having been recognised by the World Health Organisation.
The agency also disclosed that it conducts annual testing of antiretroviral, tuberculosis and malaria medicines supplied through the Global Fund.
On distribution monitoring, NAFDAC said it had deployed the GS1 technology-driven track-and-trace system to monitor the movement of COVID-19 vaccines across the country, with the relevant information stored in its Traceability Information System (TIS).
It explained that the system was now being used to monitor other vaccines and had been extended to the supply chains for narcotics and maternal and newborn health commodities.
The agency said it would apply the same technology to medical products supplied under the USG-GoN agreement to improve traceability and oversight throughout the distribution chain.
NAFDAC maintained that regulatory reliance was intended to reduce unnecessary duplication and accelerate access to quality-assured medical products without compromising its authority to make independent regulatory decisions in Nigeria.
The agency reaffirmed its commitment to enforcing its statutory mandate and safeguarding the health of Nigerians.
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