Health
NAFDAC bolsters vaccine regulation, urges local manufacturing investment
Written By: Alaba Lambert
20 Oct 2025 05:27 PM
The National Agency for Food and Drug Administration and Control (NAFDAC) has taken a significant step forward in strengthening Nigeria’s vaccine regulatory system, achieving a milestone that positions the country as a leader in pharmaceutical oversight.
In a press release issued Monday, NAFDAC announced its attainment of World Health Organization (WHO) Maturity Level 3 (ML3) status for medicines and imported vaccines in 2022, a testament to its robust and integrated regulatory framework. The agency is now calling on pharmaceutical manufacturers to invest in local vaccine production to enhance national preparedness and self-sufficiency.
The press release, signed by Director-General Prof. Mojisola Adeyeye, PhD, FAS, emphasized the urgency of this initiative, noting that Nigeria’s reliance on foreign vaccine supplies during the COVID-19 pandemic exposed the risks of overdependence on international donors.
"Nigeria must not wait for another pandemic to build vaccine self-sufficiency," Prof. Adeyeye stated, highlighting the creation of a dedicated Directorate for Vaccines, Biologics, and Medical Devices in 2024 as a key step in aligning with global best practices.
NAFDAC’s enhanced regulatory capacity includes market authorization, inspection, clinical trial oversight, post-market surveillance, and pharmacovigilance—essential components for effective vaccine regulation.
The agency also boasts an in-house laboratory, making it the only national regulatory authority in sub-Saharan Africa with such capabilities. This infrastructure positions Nigeria to ensure sustained preparedness for epidemics and pandemics, with ongoing efforts to attain ML3 status for locally manufactured vaccines, a prerequisite for WHO prequalification.
The agency is encouraging local manufacturers to begin with "fill and finish" vaccine operations—a practical step toward full-scale production. This initiative is supported by the Federal Government’s commitment under the Renewed Hope Agenda, which provides a strong foundation for local vaccine manufacturing.
NAFDAC remains dedicated to supporting manufacturers and ensuring that all locally produced vaccines meet global standards of safety, quality, and efficacy.
The announcement has sparked optimism among stakeholders, with the agency’s strengthened framework seen as a critical move to reduce Nigeria’s 100% import dependency on drugs and vaccines.
In a press release issued Monday, NAFDAC announced its attainment of World Health Organization (WHO) Maturity Level 3 (ML3) status for medicines and imported vaccines in 2022, a testament to its robust and integrated regulatory framework. The agency is now calling on pharmaceutical manufacturers to invest in local vaccine production to enhance national preparedness and self-sufficiency.
The press release, signed by Director-General Prof. Mojisola Adeyeye, PhD, FAS, emphasized the urgency of this initiative, noting that Nigeria’s reliance on foreign vaccine supplies during the COVID-19 pandemic exposed the risks of overdependence on international donors.
"Nigeria must not wait for another pandemic to build vaccine self-sufficiency," Prof. Adeyeye stated, highlighting the creation of a dedicated Directorate for Vaccines, Biologics, and Medical Devices in 2024 as a key step in aligning with global best practices.
NAFDAC’s enhanced regulatory capacity includes market authorization, inspection, clinical trial oversight, post-market surveillance, and pharmacovigilance—essential components for effective vaccine regulation.
The agency also boasts an in-house laboratory, making it the only national regulatory authority in sub-Saharan Africa with such capabilities. This infrastructure positions Nigeria to ensure sustained preparedness for epidemics and pandemics, with ongoing efforts to attain ML3 status for locally manufactured vaccines, a prerequisite for WHO prequalification.
The agency is encouraging local manufacturers to begin with "fill and finish" vaccine operations—a practical step toward full-scale production. This initiative is supported by the Federal Government’s commitment under the Renewed Hope Agenda, which provides a strong foundation for local vaccine manufacturing.
NAFDAC remains dedicated to supporting manufacturers and ensuring that all locally produced vaccines meet global standards of safety, quality, and efficacy.
The announcement has sparked optimism among stakeholders, with the agency’s strengthened framework seen as a critical move to reduce Nigeria’s 100% import dependency on drugs and vaccines.
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