The National Agency for Food and Drug Administration and Control (NAFDAC) has attributed Nigeria’s delay in achieving the World Health Organisation (WHO) Maturity Level 4 certification for vaccine lot release to the country’s limited local vaccine manufacturing capacity.
NAFDAC Director-General, Prof. Mojisola Adeyeye, urged international partners to support the development of vaccine manufacturing facilities in Nigeria, particularly through modular fill-and-finish production.
Adeyeye made the appeal at the 8th Nigeria Pharma Manufacturers’ Expo, organised in Lagos by the Pharmaceutical Manufacturing Group of the Manufacturers Association of Nigeria (PMG-MAN) in partnership with PGE Expo PVT Limited.
She said NAFDAC had met eight of the nine functions and requirements needed to become fully benchmarked for medicines and vaccines, with vaccine lot release remaining the final requirement.
“We want to call on our international partners who have been of tremendous help. Without them, we wouldn’t have been here. I want to challenge them to contribute to modular fill-and-finish vaccine manufacturing so that we can get our vaccine lot release,” she said.
“To get Lot Release-Maturity Level 4, we have figured it out and estimated the cost. It won’t cost too much. We will share that with you. Because we cannot afford to go back to where we used to be,” she said.
Adeyeye recalled that NAFDAC had previously been involved in vaccine manufacturing, saying the country needed to return to local production.
“It’s high time we went back to vaccine manufacturing,” she said.
The NAFDAC boss also credited international partners with supporting the agency’s progress towards its current WHO Maturity Level 3 status.
She said NAFDAC had strengthened its regulatory capacity and improved its personnel’s competence, noting that the agency had received international recognition for its regulatory and laboratory capabilities.
Adeyeye said NAFDAC became a member of the International Medical Device Regulators Forum in 2023, while its laboratory in Yaba became WHO prequalified in September 2023.
She added that WHO Maturity Level 3 was not a one-off achievement, explaining that the organisation periodically re-benchmarks regulatory agencies to determine whether they have maintained the required standards.
According to her, NAFDAC became the first regulatory agency in sub-Saharan Africa to be successfully re-benchmarked after initially attaining Maturity Level 3.
Adeyeye also highlighted progress in Nigeria’s pharmaceutical manufacturing sector, saying the agency’s data showed that imports of products affected by the “5+5” policy and Ceiling Initiative declined by 70 per cent between 2021 and 2025 as local manufacturers increased production.
She said the agency’s Good Manufacturing Practice (GMP) compliance efforts had also helped manufacturers improve the quality of locally produced medicines.
“We started the journey of not just the industry making products but making quality products, because this is intricately tied to the patient’s positive health outcomes during treatment. There would not be treatment failure,” she said.
The NAFDAC chief acknowledged the challenges facing local pharmaceutical manufacturers and said government incentives were important for sustaining domestic production.
She cited the 2024 Executive Order on local pharmaceutical manufacturing as an important step towards supporting the industry.
Chairman of PMG-MAN, Mr Oluwatosin Jolayemi, called for the Executive Order to be extended for another two years when it expires in March 2027.
Jolayemi, also the Managing Director/Chief Executive Officer of Daily Need Limited, said medicine security and pharmaceutical sovereignty require policy consistency, investment, capacity development and a predictable operating environment.
He said the expo provided a platform for manufacturers, regulators, investors, development partners and other stakeholders to showcase industry capabilities and build partnerships.
A total of 132 companies from Nigeria, the United States, China, Argentina, Egypt, India, Rwanda, Austria, the United Arab Emirates, France, Germany and Indonesia participated in the two-day expo.
