The National Agency for Food and Drug Administration and Control (NAFDAC) has called on international partners to support the establishment of vaccine manufacturing facilities in Nigeria, saying the absence of local production is delaying the agency’s attainment of the World Health Organisation’s (WHO) Maturity Level 4 for vaccine lot release.
Mojisola Adeyeye, director-general of NAFDAC, made the call at the 8th Nigeria Pharma Manufacturers’ Expo in Lagos, organised by the Pharmaceutical Manufacturing Group of the Manufacturers Association of Nigeria (PMG-MAN) and PGE Expo PVT Limited.
Adeyeye said international partners that had supported NAFDAC’s progress towards WHO Maturity Level 3 could help Nigeria achieve the next stage by contributing to a fill-and-finish modular vaccine manufacturing facility.
“Without them we wouldn’t have been here. I want to challenge them to contribute, to fill and finish modular vaccine manufacturing so that we can get our Vaccine Lot Release,” she said.
According to Adeyeye, NAFDAC must meet nine functions and requirements to become fully benchmarked for medicines and vaccines. She said the agency had been benchmarked in eight, with vaccine lot release remaining the final requirement.
“To get Lot Release – Maturity Level 4, we have figured it out in a way we have estimated. It’s not going to 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 rebuild that capacity.
“It’s high time we went back to vaccine manufacturing,” she said.
She also credited President Bola Tinubu’s 2024 Executive Order on healthcare manufacturing and regulatory incentives with helping to improve the operating environment for local pharmaceutical manufacturers.
“I understand the stress our manufacturers are going through. Our manufacturers are patriots because they could have given up,” Adeyeye said.
She said NAFDAC had begun its push for stronger local manufacturing through initiatives including its Good Manufacturing Practice (GMP) Roadmap, under which inspectors conducted compliance audits of more than 165 companies.
The initiative was funded by USAID and implemented by the United States Pharmacopeia.
Adeyeye said the focus was not only on increasing local production but also ensuring that medicines manufactured in Nigeria met quality standards.
She said NAFDAC data showed that imports of products affected by the “5 plus 5” and Ceiling Initiative had declined by 70 percent between 2021 and 2025, which she attributed to local manufacturers improving their capacity.
She also highlighted improvements within NAFDAC, including increased staff competence and international recognition. The agency became a member of the International Medical Device Regulators Forum in 2023, while its laboratory in Yaba became WHO-prequalified in September 2023.
Adeyeye said achieving WHO Maturity Level 3 was not a one-time recognition, as the global health body periodically reassesses regulatory agencies to ensure they maintain the required standards.
She said NAFDAC became the first regulatory agency in sub-Saharan Africa to successfully undergo re-benchmarking after attaining Maturity Level 3.
“All this is because of our industry. It’s because of our citizens,” she said.
Oluwatosin Jolayemi, chairman of PMG-MAN and managing director/CEO of Daily-Need Industries Limited, said the expo provided a platform for pharmaceutical manufacturers, regulators, investors, development partners and other stakeholders to showcase industry capabilities and build partnerships.
He commended Adeyeye for pushing the industry towards international best practices and stronger GMP compliance, saying NAFDAC’s policies were beginning to change the pharmaceutical manufacturing ecosystem.
Jolayemi called for the extension of the presidential executive order for another two years when it expires in March 2027.
He said achieving medicine security and pharmaceutical sovereignty would require policy consistency, investment, capability development and a predictable operating environment rather than short-term interventions.
A total of 132 companies from countries including the United States, China, Argentina, Egypt, India, Rwanda, Austria, the United Arab Emirates, France, Germany, Indonesia and Nigeria participated in the two-day expo.
