By Joy Odor
The World Health Organization (WHO) Global Benche Mark (GBM) has announced that National Agency for Food and Drug Administration and Control (NAFDAC) Nigeria, has attained Maturity Level Three Regulatory Agency which will give Nigeria right to start manufacturing vaccines.
Announcing the achievement during a press conference on Wednesday in Abuja, the NAFDAC Director General, Professor Mojisola Christiana Adeyeye informed that, this action, rank Nigeria the third in African and few in the low middle counties in the world.
According to her, WHO-GBM gave NAFDAC 868 recommendations in June 2019 before it would get the maturity level three, saying out the number, NAFDAC met over 600 recommendations with 147 left and the most difficult.
She maintained that in July 2021, NAFDAC reduced 147 recommendations to 33 and in October 2022, NAFDAC cleared all the recommendations through quality management system trainings that bring the successful results.
Professor Mojisola Christiana opined that the next step for NAFDAC is to start preparing fir Maturity Leve four which would enable any products approved by NAFDAC to be traded globally without any questions.
“NAFDAC is the third in Africa and one of the very few in the world to attend the WHO Maturity Level 3 regulatory agency status. Soon the agency would get Maturity Level 4 status.
“Attending 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.
“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.
”There is no fear on our side getting certification for maturity four because we have our template and we have been recertified by WHO since 2019, once we get recertified by November this year, we start self-auditing, which is going to keep us on our toes. This has to be sustained because they will be coming every three years” she stated.
Prof Adeyeye said the development indicated that NAFDAC had raised its bar in clinical trials, guidelines and procedures, regulatory inspection, laboratory listings, market control, and other regulators, among others.
She attributed the success of the agency to the dedication and commitment of staff to improving the standard, stressing that the road to success began a few weeks after she assumed duty in 2018, following her appointment by President Muhammadu Buhari to take over the affairs of the agency as director-general.
“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 realisation of the goal.
“When we started, 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.”
“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 and were left with 147 items which were the most difficult ones at that time.
“We started working at it. 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 147 recommendations and commenced work on them. In July 2021, WHO met with our officials, virtually, and confirmed that we have reduced the 147 recommendations to 33 which were the most difficult ones including regulations.
“We met all the recommendations in October, 2021. In February 2022, WHO officials returned for 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. But they asked us not to announce it until we see the letter conveying the message. The much-awaited letter came around 1 am on Wednesday.
This, she said, would afford the country’s pharmaceutical industry an avenue to thrive.
The DG NAFDAC noted that the feat could not have been achieved without the tremendous support of President Muhammadu Buhari who magnanimously gave seven hundred and thirty-six million naira to equip the laboratories.
“When I came on board, 70 to 80 per cent of our laboratories equipment were not working and President Buhari intervened and gave us seven hundred and thirty-six million (N736 million) to equip our laboratories.
”President Buhari also gave us four billion to buy more equipment and build a vaccine laboratory which is almost completed. it is the tools that earn us this, and I thank President Muhammadu Buhari for his kind gestures” she said.
Contributing, the NAFDAC Governing Board Chairman, Alhaji Yusuf Suleiman said the achievement cannot be possible without the support of the government and the hard work of the DG and staff of NAFDAC.
