National Agency for Food and Drug Administration and Control (NAFDAC) has called on international development partners to support the establishment of vaccine manufacturing facilities in Nigeria, saying the absence of local production capacity is delaying its attainment of the World Health Organisation’s (WHO) Maturity Level 4 for vaccine lot release.
The Director-General of NAFDAC, Prof. Mojisola Adeyeye, made the call at the 8th Nigeria Pharma Manufacturers’ Expo, jointly organised by the Pharmaceutical Manufacturing Group of the Manufacturers Association of Nigeria (PMG-MAN) and PGE Expo PVT Limited in Lagos.
Adeyeye said Nigeria had met eight of the nine requirements for regulatory benchmarking for medicines and vaccines, with vaccine lot release remaining the outstanding requirement for the agency to attain the next level of regulatory maturity.
She urged international partners, who had supported NAFDAC’s progress towards WHO Maturity Level 3, to extend their assistance to the establishment of modular vaccine manufacturing facilities, particularly for fill-and-finish operations.
‘We want to call on our international partners that have been of tremendous help. 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.
The NAFDAC boss said the country had the technical and regulatory capacity to achieve Maturity Level 4, adding that the remaining requirements could be addressed through targeted investments in local vaccine manufacturing.
‘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, who recalled that Nigeria previously had vaccine manufacturing capacity, said the country needed to revive local production to strengthen medicine security and reduce dependence on imported vaccines.
‘It’s high time we went back to vaccine manufacturing,’ she said.
She commended President Bola Tinubu for the 2024 Executive Order on incentives for local pharmaceutical manufacturers, saying it had helped address some of the longstanding challenges confronting the industry and accelerated efforts to unlock Nigeria’s pharmaceutical value chain.
‘I understand the stress our manufacturers are going through. Our manufacturers are patriots because they could have given up. I was championing incentives for the manufacturers until President Tinubu came on board with the Executive Order of 2024,’ she said.
Adeyeye said the policy intervention had brought greater recognition to the pharmaceutical industry and strengthened the government’s efforts to improve local manufacturing capacity.
She recalled that NAFDAC began its pharmaceutical manufacturing reform efforts with a Good Manufacturing Practice (GMP) Roadmap, which involved a nationwide compliance audit of more than 165 companies, supported by the United States Agency for International Development (USAID) and implemented by the United States Pharmacopeia.
According to her, the initiative was designed to improve the quality of locally manufactured medicines, strengthen regulatory compliance and ensure better health outcomes for patients.
She said data from 2021 to 2025 showed that imports of products covered under the ‘5+5′ policy and the Ceiling Initiative had declined by 70 per cent, attributing the development to the increased capacity of local manufacturers to produce essential medicines.
Adeyeye said NAFDAC had also invested in improving the technical competence of its personnel to ensure effective regulation and sustain the quality of locally manufactured pharmaceutical products.
She noted that the agency became a member of the International Medical Device Regulators Forum in 2023, while its laboratory in Yaba, Lagos, attained WHO prequalification in September of the same year.
The NAFDAC director-general said the WHO’s Maturity Level 3 recognition was subject to continuous assessment and re-benchmarking to ensure that regulatory agencies maintained consistent standards.
She added that NAFDAC became the first regulatory agency in sub-Saharan Africa to successfully undergo re-benchmarking after attaining Maturity Level 3.
Adeyeye said the agency’s progress reflected the combined efforts of its personnel, local pharmaceutical manufacturers and the Nigerian public, stressing that regulatory agencies were assessed against the same international standards, irrespective of their countries’ economic status.
Earlier, the Chairman of PMG-MAN, Mr Oluwatosin Jolayemi, described the expo as a major platform for pharmaceutical manufacturing in Central and West Africa, bringing together manufacturers, regulators, investors, development partners and other stakeholders to explore investment opportunities and strengthen the industry.
Jolayemi, who is also the Managing Director and Chief Executive Officer of Daily Need Limited, commended Adeyeye for her commitment to improving pharmaceutical manufacturing standards and ensuring compliance with international GMP requirements.
He said NAFDAC’s policies were gradually transforming the pharmaceutical manufacturing ecosystem but stressed the need to sustain the gains through consistent government support.
The PMG-MAN chairman called on the Federal Government to extend the 2024 Executive Order on pharmaceutical manufacturing incentives for another two years when it expires in March 2027.
He argued that achieving medicine security and pharmaceutical sovereignty required long-term interventions, policy consistency, sustained investment, capacity development and a predictable operating environment.
A total of 132 companies from Nigeria, the United States, China, Argentina, Egypt, India, Rwanda, Austria, the United Arab Emirates, France, Germany and Indonesia, among others, participated in the two-day expo, which focused on strengthening pharmaceutical manufacturing and expanding international partnerships.