From Fred Ezeh, Abuja
The World Health Organisation (WHO) has certified National Agency for Food and Drug Administration and Control (NAFDAC) as a level three regulatory agency.
This means that NAFDAC has improved in standards in terms of administration, marketing and post-marketing, production registration and several other areas.
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It also means that they have improved in clinical trials, guidelines and procedures, regulatory inspection, laboratory listings, market control, and other regulatory
NAFDAC Director-General Prof Mojisola Adeyeye, who disclosed the development at a press conference in Abuja on Wednesday, said the feat was a result of years of hard work, dedication and commitment to the cause of improving the operations of NAFDAC.
‘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,’ she stated.
‘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.
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‘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 was 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 1am on Wednesday.’
The NAFDAC boss confirmed that the agency is the third in Africa and one of the very few in the world to attend the WHO maturity level three regulatory agency status, stating that the next step is maturity level four which will bring greater opportunities for the pharmaceutical companies.
She said: ‘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.’