The National Agency for Food and Drug Administration and Control (NAFDAC) has urged Nigerian pharmaceutical manufacturers to invest in local vaccine production to achieve national self-sufficiency and reduce dependence on foreign suppliers.
Director-General of NAFDAC, Prof. Mojisola Adeyeye, PhD, FAS, made the call while highlighting lessons from the COVID-19 pandemic, which exposed Nigeria’s vulnerability due to overreliance on international donors for vaccine supply.
She noted that NAFDAC has significantly strengthened its vaccine, biologics, and medical devices regulatory systems through institutional restructuring and global benchmarking. Following the creation of a dedicated Directorate for Vaccines, Biologics, and Medical Devices in 2024, the agency now operates in line with international best practices.
Nigeria achieved the World Health Organization (WHO) Maturity Level 3 (ML3) status for medicines and imported vaccines in 2022 — a major milestone that signifies a stable and well-defined regulatory framework. Efforts are now underway to attain ML3 for locally manufactured vaccines, a requirement for WHO prequalification.
Prof. Adeyeye emphasized that NAFDAC’s regulatory capabilities — including market authorization, inspection, clinical trial oversight, post-market surveillance, and pharmacovigilance — are critical to effective vaccine control. She added that the agency’s in-house laboratory for vaccines and biologics makes it the only regulatory authority in sub-Saharan Africa with such capacity.
To ensure sustained epidemic preparedness, NAFDAC has developed emergency response guidelines and continues to strengthen national regulatory readiness. The agency is encouraging local manufacturers to start with “fill and finish” operations as a stepping stone to full-scale vaccine production.
According to Prof. Adeyeye, the strengthened regulatory system, backed by the Federal Government’s Renewed Hope Agenda, provides a solid foundation for developing a robust local vaccine manufacturing sector. She reaffirmed NAFDAC’s commitment to supporting manufacturers and ensuring that all locally produced vaccines meet global standards of safety, quality, and efficacy.
