The National Agency for Food and Drug Administration and Control (NAFDAC) has called on international development partners to support Nigeria in establishing local vaccine manufacturing facilities, saying the absence of such capacity is holding back the country’s bid to attain the World Health Organisation (WHO) Maturity Level 4 for vaccine lot release.
NAFDAC Director-General, Prof. Mojisola Adeyeye, made the appeal at the 8th Nigeria Pharma Manufacturers Expo in Lagos, organised by the Pharmaceutical Manufacturers Group of the Manufacturers Association of Nigeria (PMG-MAN) in partnership with PGE Expo PVT Limited.
Adeyeye said NAFDAC had achieved eight of the nine functions and requirements needed to be fully benchmarked for the regulation of medicines and vaccines, with vaccine lot release remaining the final requirement.
She therefore urged international partners who had supported the agency’s regulatory development to assist Nigeria in establishing fill-and-finish modular vaccine manufacturing facilities.
“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.
According to her, Nigeria already has the regulatory capacity needed for Maturity Level 4, but local vaccine production remains critical to completing the process.
“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 added.
Adeyeye recalled that Nigeria once manufactured vaccines, stressing the need for the country to return to local production as part of efforts to strengthen health security and reduce dependence on imported medical products.
“It’s high time we went back to vaccine manufacturing,” she declared.
The NAFDAC boss also commended President Bola Ahmed Tinubu for the 2024 Executive Order aimed at supporting local pharmaceutical manufacturing, saying the policy had helped address some of the challenges confronting domestic manufacturers.
She described Nigerian pharmaceutical manufacturers as patriots for remaining in business despite difficult operating conditions.
“I understand the stress our manufacturers are going through. Our manufacturers are patriots because they could have given up,” Adeyeye said.
She recalled that NAFDAC had embarked on a Good Manufacturing Practice (GMP) Roadmap under which inspectors carried out compliance audits of more than 165 pharmaceutical companies across the country.
The exercise, she said, was supported by USAID and implemented by the United States Pharmacopeia, with the objective of ensuring that local manufacturers not only produced medicines but also met international quality standards.
Adeyeye further disclosed that NAFDAC’s data showed a 70 per cent reduction between 2021 and 2025 in imports of products affected by the 5+5 policy and Ceiling Initiative, attributing the development to increased capacity among local manufacturers.
She said the agency had also continued to strengthen the competence of its personnel, stressing that regulatory excellence depended on the quality and capacity of its workforce.
According to her, NAFDAC became a member of the International Medical Device Regulators Forum in 2023, while its laboratory in Yaba, Lagos, became WHO-prequalified in September 2023.
Adeyeye explained that WHO Maturity Level 3 was not a permanent recognition, as regulatory agencies were periodically reassessed to ensure they remained consistent, resilient and compliant with international standards.
She said NAFDAC became the first regulatory agency in sub-Saharan Africa to successfully undergo the re-benchmarking process on its first attempt.
Meanwhile, the Chairman of PMG-MAN, Mr Oluwatosin Jolayemi, said the expo remained a major platform for pharmaceutical manufacturers, regulators, investors and development partners to showcase industry capacity and forge partnerships.
Jolayemi, who is also Managing Director/Chief Executive Officer of Daily-Need Limited, commended Adeyeye for her efforts to improve quality and Good Manufacturing Practice compliance in the pharmaceutical sector.
He said NAFDAC’s policies were beginning to transform the industry but warned that the gains must be sustained.
Jolayemi called for the extension of the Presidential Executive Order for another two years after its expiration in March 2027, arguing that achieving medicine security and pharmaceutical sovereignty would require sustained policy consistency, investment and capacity development.
The two-day expo attracted 132 companies from countries including the United States, China, Argentina, Egypt, India, Rwanda, Austria, the United Arab Emirates, France, Germany and Indonesia, as well as Nigeria.
