NAFDAC, the National Agency for Food and Drug Administration and Control in Nigeria has met the World Health Organisation’s (WHO) maturity level three criterion for pharmaceutical regulation and vaccine production.
Prof. Mojisola Adeyeye, the Director-General of NAFDAC, made the announcement while briefing journalists in Abuja on Wednesday.
The NAFDAC boss added that maturity level three status prepares Nigeria for the local production of vaccines.
She said: “This is to bring the news that NAFDAC has been categorised as a maturity level three regulatory agency.
“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 quarter, that lab will be ready.”
She stated that the agency was working hard to achieve maturity level four, which would allow any NAFDAC-approved product to be traded globally.
Prof. Adeyeye praised President Muhammadu Buhari for allocating N736 million to equip the laboratory and another N4 billion to purchase further equipment and construct the vaccine laboratory.
She noted the process to accomplish the achievement began five weeks after she returned as the agency’s director-general in January 2018.
WHO set 868 criteria for the agency to achieve before achieving maturity level three status, she said, adding that the agency had met over 600 of them by June 2019.
The COVID-19 epidemic halted the voyage in 2020, but the agency was able to revisit the 147 suggestions and had only 33 left by July 2021, according to Prof Adeyeye.
According to her, between October 2021 and February 2022, when WHO inspectors visited the agency for the final inspection, the agency was able to clear the remaining ones.
She said she received the letter confirming the agency as a maturity level three regulatory agency in the early hours of Wednesday, adding that NAFDAC was Africa’s third and one of the world’s largest regulatory agencies.
Meanwhile, the World Health Organisation said in a statement on Wednesday that Nigeria and Egypt’s attainment of maturity level three means that their medical products regulatory agencies have been found to function well and that they may be eligible for inclusion in the transitional WHO Listed Authorities, a list that will include the world’s reference regulators.
Egypt has acquired maturity level 3 in the regulation of vaccines (both locally produced and imported), whereas Nigeria has reached maturity level 3 in the regulation of pharmaceuticals and imported vaccines.
