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, on 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.
Attaining Maturity Level 3
In a press briefing in Abuja on Wednesday, 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”.
The official also said the vaccine laboratory in Oshodi, Lagos, which is currently under construction by the government, would be ready by the middle of 2022.
About WHO’s maturity levels
The WHO assessments of national regulatory systems aim to strengthen oversight and identify both strengths and gaps to inform technical support, the health body said.
There are four levels of regulatory systems classification starting from Level 1, where only some elements of regulation exist, and up to Level 4 corresponding to the advanced regulatory system. Level 3 indicates that the system is well-functioning and integrates all required elements to guarantee its stable performance.
Singapore medicines’ regulator is the world’s first to achieve level 4 – the highest maturity level in WHO classification.
WHO’s assessment of regulatory authorities is based on the ‘Global Benchmarking Tool’ – an evaluation tool that checks regulatory functions against a set of more than 260 indicators – covering core regulatory functions such as product authorisation, testing of products, market surveillance and the ability to detect adverse events – to establish their level of maturity and functionality. Regulatory authorities that reach maturity levels 3 and 4 will be eligible for inclusion among WHO-listed authorities, after additional evaluation of their performance.
The benchmarking of Egypt and Nigeria’s regulators was carried out by a WHO-led team of international experts. In February and March 2022, WHO conducted a formal evaluation of the authorities and found them to perform well against most of the indicators in the Global Benchmarking Tool.
“Egypt and Nigeria have come a long way to improve their regulatory work and performance,” said Mariangela Simao, WHO’s assistant director-general for Access to Health Products. “Given that medical products regulatory oversight and manufacturing must work in tandem, this is very good news for access to quality health products on the African continent.”
“Nigeria has strengthened its medicines regulatory system to ensure safety, quality and effectiveness of medical products manufactured, imported, or distributed within the country,” WHO said.