The Director-General of the National Agency for Food and Drug Administration and Control (NAFDAC), Prof. Mojisola Adeyeye, has urged pharmaceutical manufacturers to invest in the local production of human vaccines.
In a statement on Monday, Prof. Adeyeye emphasised that Nigeria must not wait for another pandemic to build vaccine self-sufficiency, noting that the country’s reliance on foreign supplies during COVID-19 exposed the risks of overdependence on international donors.
She revealed that NAFDAC has strengthened its regulatory system for vaccines, biologics, and medical devices through institutional restructuring and global benchmarking.
“Following the creation of a dedicated Directorate for Vaccines, Biologics, and Medical Devices in 2024, NAFDAC now aligns with international best practices and operates at a level comparable to advanced regulatory systems worldwide.
“The Agency achieved World Health Organization (WHO) Maturity Level 3 (ML3) status for medicines and imported vaccines in 2022, a major milestone demonstrating that Nigeria’s regulatory system functions at a stable, well-defined, and integrated level. Efforts are now ongoing to attain ML3 for locally manufactured vaccines, which is required for WHO prequalification,” the DG said.
Adeyeye highlighted the agency’s regulatory capacities, including market authorisation, inspection, clinical trial oversight, post-market surveillance, and pharmacovigilance, explaining that all are essential components for effective vaccine regulation.
She disclosed that the regulatory body also operates an in-house laboratory for vaccines, biologics, and medical devices, making it the only national regulatory authority in sub-Saharan Africa with such capacity.
Adeyeye continued: “To ensure sustained preparedness for epidemics and pandemics, NAFDAC has developed guidelines for emergency response and continues to strengthen national regulatory readiness. The Agency is encouraging local manufacturers to begin with ‘fill and finish’ vaccine operations, as a practical step toward full-scale production.
“The strengthened regulatory framework, combined with the Federal Government’s commitment under the Renewed Hope Agenda, provides a strong foundation for local vaccine manufacturing in Nigeria.”
She reiterated NAFDAC’s commitment to supporting manufacturers and ensuring that all locally produced vaccines meet global standards of safety, quality, and efficacy.
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