By Hassan Zaggi
The World Health Organisation (WHO) has certified the National Agency For Food And Drug Administration and Control (NAFDAC) as a ‘maturity level three’ agency.
With the attainment of this status, any drug approved by NAFDAC will be accepted globally.
NAFDAC is among the very few African countries that have attained the WHO maturity level three regulatory agency status.
The Director General of NAFDAC, Mojisola Adeyeye, disclosed this at a media briefing on Wednesday, in Abuja.
The certification, she explained, means that NAFDAC has improved in clinical trials, guidelines and procedures, regulatory inspection, laboratory listings, market control, and other regulatory operations.
Adeyeye who applauded the staff of the agency for the success recorded, explained that: “We started this journey in January 2018, five weeks after my resumption as NAFDAC Director-General. It was a torturous, tasking and highly demanding journey, but I went through it with the support of my directors, governing council and other staff who made different kinds of sacrifices towards the realization of the goal.
“When we started, the WHO listed 868 recommendations which we must meet before we get to maturity level three status.
“Initially, it sounded impossible, but my directors stood by me all the way, in addition to many others who did all forms of sacrifices to ensure we achieve the feat.”
She further disclosed that: “In June 2019, WHO officials visited NAFDAC headquarters in Abuja to commence the benchmarking process. Out of the 868 recommendations they listed, we were able to meet over 600 of them.
“We started working on the remaining recommendations. We organised town hall meetings and retreats for everyone involved along the chain. We made sure that NAFDAC is on the quality system, and that helped us greatly to achieve the feat.
“In 2020, the COVID-19 pandemic came and interrupted our programmes. It took a year out of our scheduled time.
“After the COVID-19 fever, we picked up from where we stopped in 2020. We revisited the remaining recommendations and commenced work on them.
“In July 2021, WHO met with our officials, virtually, and confirmed that we have reduced the remaining recommendations to 33 which were the most difficult ones including regulations.”
According to her: “We met all the recommendations in October 2021. In February 2022, WHO officials returned for a final inspection and were glad that all items we submitted and claimed to have were intact.
“That was when they told us that we are successful and had met the criteria for maturity level three regulatory agency status.”
The next step, Adeyeye revealed, is maturity level four which will bring greater opportunities for the pharmaceutical companies.
“Attaining maturity level four means that any product approved by NAFDAC can be traded globally. Nevertheless, with the maturity level three status, we are good to go in terms of vaccine manufacturing which we do through our manufacturers. This couldn’t have been possible if we didn’t attend maturity level three regulatory agency status. That’s the immediate benefit.”
On vaccine manufacturing, the NAFDAC Director General, said: “We are building the vaccine laboratory in Oshodi, Lagos, which will be ready by the middle of the year or early third quarter. This success was because of the support we got from the government.”
Speaking, the Chairman of the NAFDAC Governing Board, Yusuf Suleiman, applauded the DG and the entire staff of NAFDAC for their doggedness and effort in achieving the level three status.
He noted that the WHO’s maturity level three certification means that the agency can compete with other sister agencies globally and that medicines and other products approved by NAFDAC will be acceptable and respected globally.
