The World Health Organization has designated the National Agency For Food And Drug Administration And Control (NAFDAC) as a category 3 regulatory agency, allowing it to participate on the global market.
NAFDAC can now project pharmaceuticals developed in Nigeria into the worldwide market after achieving regulatory maturity level three.
At a press conference, NAFDAC Director-General Mojisola Adeyeye noted that the certification also signifies that the quality of medications made in Nigeria meets international standards, that NAFDAC laboratories are operating at full capacity, and that Nigeria may now confidently produce vaccines.
The accreditation also shows that Nigeria has improved in clinical trials, established world-standard norms and processes, expanded regulatory inspection, laboratory listings, market control, and other regulatory measures, according to Adeyeye.
She claimed the agency went through 868 recommendations, or exams, before reaching the maturity level three stage, and that the WHO had physically examined NAFDAC premises and processes before awarding the accreditation.
“All of our tests and suggestions were marked by the global benchmarking team.
“WHO visited NAFDAC headquarters in June 2019 to begin the benchmarking process. We were all supposed to satisfy nearly 600 of the 868 suggestions, leaving only 147, which were the most challenging at the time.
” In 2020, the COVID-19 epidemic struck, delaying our plans by a year. We initially scaled through 600 in 2019, then strengthened our quality management system and scaled through another 147 in 2020, and the final 33 in 2021.
“When COVID-19 arrived, we raised N4 billion to purchase vaccination lab equipment. What maturity level 3 prepares us for currently is vaccine manufacturing through our manufacturers, which would not have been conceivable if we hadn’t attended maturity level 3.
“Now that we are stronger, Nigeria can make our own vaccinations.”