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NAFDAC scaled through 868 hurdles to bag WHO maturity classification –DG

The Director-General of Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC), Mojisola Adeyeye, has explained how the agency bagged “maturity level 3” certification from the World Health Organisation (WHO).

WHO had, last Wednesday, announced that Egypt’s and Nigeria’s medical products regulatory agencies have become the third and fourth in Africa to attain regulatory system “Maturity Level 3” – the second highest in the four-tiered WHO classification of national medicines regulatory systems.

The two countries join Ghana and Tanzania as effective regulatory systems on the African continent. Several other African regulators are currently under assessment.

According to WHO, the implication of NAFDAC’s new status is that it has been found to function “well and that it could be eligible for inclusion into the transitional WHO Listed Authorities- a list that will comprise the world’s regulators of reference – that is, regulatory authorities that should be globally recognised as meeting WHO and other international standards,” the global health body said in a statement.

Egypt has reached maturity level 3 for vaccine regulation (locally produced and imported) and Nigeria for medicines and imported vaccines.

In a press briefing in Abuja last week, while announcing the maturity level 3 certification, Mrs Adeyeye noted that scaled through 868 hurdles to attain the status.

She said; “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.”

Mrs Adeyeye, a professor, noted that WHO officials had visited NAFDAC headquarters in Abuja in 2019, to commence the benchmarking process.

She noted that out of the 868 recommendations the global organisation listed, NAFDAC was able to meet over 600 and was left with 147 items which, she added, were the most difficult ones at the time.

She said; “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 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. But they asked us not to announce it until we see the letter conveying the message. The much-awaited letter came around 1a.m on Wednesday”.

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