The National Agency for Food and Drug Administration and Control (NAFDAC) has attained the World Health Organization (WHO) ‘s maturity level three benchmark for regulation of medicines and importation of vaccines.
The Director-General of NAFDAC, Prof. Mojisola Adeyeye, made the disclosure on Wednesday while briefing newsmen in Abuja.
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She said: “This is to bring the news that NAFDAC has been categorized as a maturity level three regulatory agency.”
The NAFDAC boss added that maturity level three status prepares Nigeria for the local production of vaccines.
She said, “What maturity level 3 prepares us for now is the manufacturing of our own vaccine because NAFDAC is stronger.
“We are building the vaccine laboratory in Oshodi. By the middle of the year or early third quatre, that lab will be ready.”
She said the agency was working hard towards attaining maturity level four, adding that this would mean any product approved by NAFDAC could be traded globally.
Prof Adeyeye applauded President Muhammadu Buhari for approving N736 million to equip its laboratories, and another N4 billion to buy more equipment and build the vaccine laboratory.
She said the journey towards achieving the feat began in January 2018, five weeks after she resumed as the agency’s director-general.
She said WHO listed 868 recommendations that the agency must meet before getting to maturity level three status, adding that by June 2019, the agency had met over 600 of them.
Prof Adeyeye said the journey was disrupted by the COVID-19 pandemic in 2020 but the agency was able to revisit the 147 recommendations and had only 33 left by July 2021.
According to her, the agency was able to clear the remaining ones between October 2021 and February 2022 when WHO officials visited the agency for the final inspection.
While saying she got the letter certifying the agency as a maturity level three regulatory agency in the early hours of Wednesday, she added that NAFDAC was the third agency in Africa and one of the very few in the world (from low-income countries) to attain the status.
She said the maturity level three status meant that Nigeria’s drugs, clinical trial guidelines, regulatory inspection, laboratory testing and listing, market control, market authorization, and registration of products were now better.
The Chairman NAFDAC Governing Board, Yusuf Suleiman said the agency’s maturity level places the country on a pedestal for global acceptance.
Meanwhile WHO, in a statement on Wednesday, said that Nigeria and Egypt’s achievement of maturity level three means that their medical products regulatory agencies have been found to function well and that they could be eligible for inclusion into the transitional WHO Listed Authorities, a list that will comprise the world’s regulators of reference.
Egypt reached maturity level 3 for vaccines regulation (locally produced and imported) and Nigeria for medicines and imported vaccines.
The statement said WHO’s assessment of regulatory authorities is based on the ‘Global Benchmarking Tool’ – an evaluation tool that checks regulatory functions against a set of more than 260 indicators – covering core regulatory functions such as product authorization, testing of products, market surveillance and the ability to detect adverse events – to establish their level of maturity and functionality.
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