The World Health Organisation, WHO has certified the National Agency For Food And Drug Administration And Control (NAFDAC) as a category 3 regulatory agency, giving it powers to compete in the international market.
Achieving the maturity level three regulatory status implies that NAFDAC can now project drugs manufactured in Nigeria into the international market.
The Director-General, NAFDAC, Mojisola Adeyeye at a press briefing said the certification also means that the quality of drugs manufactured in Nigeria is of international standard, that NAFDAC laboratories are functioning at the required capacity and that Nigeria can now confidently produce vaccines.
Adeyeye said the certification also indicates that Nigeria has now improved in clinical trials, produced world standard guidelines and procedures, increased regulatory inspection, laboratory listings, market control, and other regulatory
operations.
She said the agency scaled through 868 recommendations, akin to tests before it attained the maturity level three-stage, informing that the WHO had conducted physical examinations of NAFDAC facilities and systems before issuing the certification.
”The global benchmarking team marked all our tests and recommendations.
“In June 2019, WHO visited NAFDAC headquarters to commence the benchmarking process. Out of the 868 recommendations, we were all to meet over 600 recommendations and had 147 left which were the most difficult ones at that time.
” In 2020, COVID-19 pandemic came and took a year out of our scheduled time. We scaled through 600 at the initial stage in 2019, then we improved our quality management system and scaled through another 147, in 2021 we completed the remaining 33.
“When COVID-19 came, we got N4 billion to get equipment for a vaccine lab. What maturity level 3 prepares us for now is the manufacturing of vaccines through our manufacturers which wouldn’t have been possible if we didn’t attend maturity level 3.
”Now Nigeria can manufacture our own vaccines because we are stronger”
