Mojisola Adeyeye, director-general of the National Agency for Food and Drug Administration and Control (NAFDAC), has said the World Health Organisation’s re-benchmarking of NAFDAC and the Pharmacists Council of Nigeria (PCN) will strengthen the country’s capacity to produce vaccines and medicines.
The WHO has officially reaffirmed Nigeria’s achievement of Maturity Level 3 (ML3) status for the regulation of medicines and vaccines, effective from 30 June 2025.
The recognition followed a re-benchmarking exercise conducted by the WHO in Abuja and Lagos from 25 to 29 November 2024, along with five follow-up institutional development plan meetings held between February and May 2025.
“As a maturity level 3 country, we can manufacture vaccines. No country should manufacture a vaccine without a maturity level 3. If you don’t have international standards, what are you going to manufacture? “Adeyeye said this Tuesday while briefing the press.
The NAFDAC DG informed that the agencies remain the first national regulatory authority in Africa to sustain the status, even though they were not the first regulatory agency in Africa to achieve maturity level 3, coming after Tanzania and Ghana.
In addition to enabling vaccine production, the DG said the status will strengthen collaboration and communication between the NAFDAC and PCN, noting that both agencies “used to fight a lot, like cat and dog”
“The two agencies cannot play in the same field wherein there is no communication or effective communication. What it means is that we have standards that are agreeable, that we compare notes”, she added.
Explaining the attainment of the status, Adeyeye said the agencies passed 267 sub-indicator requirements.
Adeyeye said NAFDAC is now working towards achieving Maturity Level 4 (ML4), and has met nearly 50% of the target. “For level 4, we have 57 indicators. We have already closed 27 of them. We have about 30 indicators left. We have already started working again.”
Attaining ML4 would allow Nigeria to become a Listed Authority (WLA), enabling it to export pharmaceuticals.
“When we get to WLA, we become a Stringent Regulatory Authority. Products that we approve after that date can be sold anywhere in the world. That will be music to the president’s ears, o any Nigerian’s ears. And there is a confidence that is building across the globe about Nigeria”, she enthused.
“If we can trade globally, we increase our GDP. You will see investment coming into the country. Because the investor knows that the regulatory agency is strong. There will be more jobs for our children. I’m sure there will be less ‘Japa'”, she further said.
Ibrahim Ahmed, Registrar of the PCN, said the agencies are not resting on their laurels despite the status.
“We have not simply attained Maturity Level 3 and gone to sleep. We are looking forward and moving ahead. Recognising the critical role of facility licensure in the pharmaceutical landscape, we commenced the retraining of all national pharmaceutical inspectors just yesterday. This week-long programme is aimed at raising our game,” he said.
Ahmed explained that Nigeria’s ML3 attainment followed a thorough evaluation of regulatory tools, including laws, regulations, guidelines and standard operating procedures used for inspections.
“The quality management system was critically assessed, and all outstanding gaps were closed. WHO looked at the regulatory system, our operational environment, staffing levels, availability of computers and vehicles, and the tools we use to ensure effective regulation,” he said.
