By Chioma Obinna
LAGOS — The National Agency for Food and Drug Administration and Control, NAFDAC, has said Nigeria’s failure to produce vaccines locally is delaying the country’s attainment of the World Health Organisation, WHO, Maturity Level 4 for vaccine lot release.
The agency said Nigeria had met eight of the nine requirements benchmarked for full regulatory maturity, with vaccine lot release remaining the outstanding requirement.
Consequently, NAFDAC has called on international partners to support the establishment of fill-and-finish modular vaccine manufacturing facilities in Nigeria, stressing the need for the country to return to local vaccine production.
The NAFDAC Director-General, Prof. Mojisola Adeyeye, made the call at the 8th Nigeria Pharma Manufacturers’ Expo in Lagos, organised by the Pharmaceutical Manufacturers Group of the Manufacturers Association of Nigeria, PMG-MAN, in collaboration with PGE Expo PVT Limited.
Adeyeye acknowledged the contribution of international partners to NAFDAC’s progress towards WHO Maturity Level 3, urging them to extend their support to vaccine manufacturing.
She said, “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.”
According to her, NAFDAC had been benchmarked against eight of the nine functions required for full regulatory maturity, leaving vaccine lot release as the only outstanding requirement.
She said the cost of achieving the milestone had been estimated and was within reach, stressing that Nigeria could not afford to lose the progress already recorded.
“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 declared that “it’s high time we went back to vaccine manufacturing,” linking local vaccine production to efforts to strengthen Nigeria’s pharmaceutical manufacturing base and reduce dependence on imported medicines.
She said imports of pharmaceutical products under the “5 plus 5” and Ceiling Initiative declined by 70 per cent between 2021 and 2025, attributing the development to increased domestic production by local manufacturers.
The NAFDAC boss also said the agency had strengthened its regulatory capacity, stressing that effective regulation was essential to ensuring that medicines produced locally met required quality standards.
“You cannot give what you don’t have,” she said, while highlighting efforts to build the capacity of NAFDAC personnel.
She said NAFDAC became a member of the International Medical Device Regulators Forum, IMDRF, in 2023, while its laboratory in Yaba was pre-qualified by WHO in September of the same year.
Adeyeye said WHO Maturity Level 3 was not a permanent status, as the global health body would return to re-benchmark the agency.
She added that NAFDAC had become the first regulatory agency in sub-Saharan Africa to be successfully re-benchmarked on its first attempt.
“All this is because of our industry. It’s because of our citizens,” she said.
Adeyeye also commended pharmaceutical manufacturers for remaining in business despite difficult operating conditions, noting that the Federal Government’s 2024 Executive Order introduced incentives aimed at supporting local pharmaceutical production.
“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.
She added that the gains recorded in the regulatory and pharmaceutical manufacturing sectors had not received sufficient attention until the presidential intervention.
Meanwhile, the Chairman of PMG-MAN, Mr Oluwatosin Jolayemi, called for the extension of the presidential executive order on pharmaceutical manufacturing incentives for another two years when it expires in March 2027.
Jolayemi, who is also Managing Director/Chief Executive Officer of Daily-Need Industries Limited, said the extension was necessary to sustain progress in strengthening local pharmaceutical manufacturing.
He described medicine security and pharmaceutical sovereignty as long-term goals requiring policy consistency, investment, capacity development and a predictable operating environment.
Jolayemi said the expo remained a platform for pharmaceutical manufacturers, regulators, investors, development partners and other stakeholders to showcase capabilities, forge partnerships and discuss the future of the industry.
He commended NAFDAC for efforts to align Nigeria’s pharmaceutical regulatory system with international best practices, particularly in Good Manufacturing Practice, GMP.
Adeyeye had earlier disclosed that NAFDAC commenced a GMP roadmap and strengthened compliance monitoring across the industry.
She said routine GMP inspections had covered more than 165 companies, with support from the United States Agency for International Development, USAID, and technical execution by the United States Pharmacopeia.
According to her, the objective was not merely to increase the number of medicines manufactured locally but to ensure that the products met quality standards capable of improving treatment outcomes.
“We started the journey of not just the industry making products but making quality products because this is intricately tied to the way the patient’s positive health outcomes during treatment. There would not be treatment failure,” she said.
The two-day expo attracted 132 participating companies from Nigeria and countries including the United States, China, Argentina, Egypt, India, Rwanda, Austria, the United Arab Emirates, France, Germany and Indonesia.
The post Vaccine production delay stalls WHO Level 4 — NAFDAC appeared first on Vanguard News.