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The National Agency for Food and Drug Administration and Control (NAFDAC) has called on international partners to support Nigeria’s efforts to establish vaccine manufacturing facilities, saying the absence of local production is delaying the country’s attainment of the World Health Organisation (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 organised in Lagos by the Pharmaceutical Manufacturing Group of the Manufacturers Association of Nigeria (PMG-MAN) and PGE Expo PVT Limited.
Adeyeye said Nigeria had met eight of the nine functions and requirements required for full benchmarking of its medicines and vaccines regulatory system, with vaccine lot release remaining the final requirement.
She appealed to international development and health partners that had supported NAFDAC’s regulatory transformation to also contribute to the establishment of a fill-and-finish modular vaccine manufacturing facility in the country.
“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 has most of what is required to attain the WHO Level 4 status, except local vaccine manufacturing capacity.
“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, stressing the need for the country to revive local production. “It’s high time we went back to vaccine manufacturing,” she said.
The NAFDAC boss also commended President Bola Tinubu for the 2024 Executive Order aimed at providing incentives and strengthening local pharmaceutical manufacturing, describing it as a major boost to an industry that had operated for years under difficult conditions.
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She said the agency’s regulatory reforms, including strengthened Good Manufacturing Practice (GMP) compliance, had contributed to a 70 per cent reduction in imports of products affected by the “5 plus 5” policy and Ceiling Initiative between 2021 and 2025.
Adeyeye said the agency’s GMP compliance efforts included inspections of more than 165 companies across the country, while its staff capacity had also been strengthened to improve regulatory performance.
She said the reforms had attracted international recognition, including the WHO prequalification of NAFDAC’s Yaba laboratory in September 2023.
She added that WHO had subsequently re-benchmarked NAFDAC, making the agency the first in sub-Saharan Africa to successfully undergo re-benchmarking at the first attempt.
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 capabilities and forge partnerships.
Jolayemi, who is also Managing Director/Chief Executive Officer of Daily Need Limited, commended Adeyeye for pushing the industry towards international standards in quality and GMP compliance.
He, however, called for the extension of the 2024 presidential Executive Order for another two years when it expires in March 2027.
He said medicine security and pharmaceutical sovereignty could not be achieved through short-term interventions, but required policy consistency, investment, capacity development and a predictable operating environment.
The two-day expo attracted 132 participating companies from Nigeria, the United States, China, Argentina, Egypt, India, Rwanda, Austria, the United Arab Emirates, France, Germany and Indonesia, among others.
