– 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.
By Biola Lawal
Flowerbudnews: The National Agency for Food and Drug Administration and Control (NAFDAC), has assured Nigerians that all Nigerian Government-backed medicines and vaccines that come into the country are tested for quality, safety, and efficacy.
NAFDAC Director General, Prof. Mojisola Adeyeye, gave the assurance in a public statement entitled: NAFDAC TESTS QUALITY AND SAFETY OF ALL MEDICINES AND VACCINES UNDER PERTINENT AGREEMENTS WITH OTHER NATIONS AND FOLLOWS UP THE DISTRIBUTION IN-COUNTRY USING TRACK AND TRACE TECHNOLOGY-DRIVEN SYSTEM.
Prof.Adeyeye said that ‘the United States-Nigerian Government medical (USG-GoN) products are for HIV/AIDS and are being supplied to fill the void that was created by the USAID exit.”
She stressed that NAFDAC had set regulatory oversight precedence in ensuring the health of the nation is safe guarded with the testing of ALL COVID-19 vaccines given to Nigeria during the pandemic.
Prof. Adeyeye disclosed that the vaccines were tested at the NAFDAC Yaba Vaccine, Biologics and Medical Devices laboratory in Yaba despite the fact they have been declared safe by the World Health Organization.
‘cALL Anti-retroviral, tuberculosis and malarial (ATM) drugs that are supplied by Global Fund are tested annually by NAFDAC, ” She added.
Prof. Adeyeye stated further:
As stated by the Coordinating Minister of Health and Social Welfare CMHSW), Prof Ali Pate, NAFDAC continues to exercise its statutory responsibility for 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 USG-GoN MoU refers to NAFDAC’s existing regulatory-reliance framework with US FDA where products manufactured in the USA, approved through the very stringent US FDA regulations are given expedited approval because of the stringency given to the process by US FDA.
If the products donated are not manufactured in the USA, all of the products will be tested for quality, safety and efficacy by NAFDAC. That is, NAFDAC retains its responsibility for Nigeria’s own decision.
NAFDAC used GS1 technology-driven Track and Trace system to monitor where all the COVID-19 vaccines brought into the country during the pandemic were distributed.
The data are in the NAFDAC Traceability Information System (TIS). We now use the same Track and Trace system to monitor non-COVID-19 vaccines.
The Agency has started using TIS to monitor the supply chain or distribution of narcotics, maternal and newborn child 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.
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.
