The National Agency for Food and Drug Administration and Control (NAFDAC) has urged Nigerian pharmaceutical manufacturers to invest in local vaccine production as part of efforts to enhance health security and achieve self-sufficiency in vaccine supply.
The National Agency for Food and Drug Administration and Control (NAFDAC) has reaffirmed its commitment to strengthening Nigeria’s vaccine regulatory framework and boosting local manufacturing capacity. The agency emphasized that it is essential for the country to reduce dependence on foreign donors and imported vaccines, as seen during the COVID-19 pandemic, which exposed the vulnerabilities in Nigeria’s public health system.
“Nigeria must not wait for another pandemic to build vaccine self-sufficiency,” said Prof. Mojisola Adeyeye, Director-General of NAFDAC. “Our strengthened regulatory systems are designed to ensure that locally manufactured vaccines meet global standards of quality, safety, and efficacy.”
Institutional Strengthening and Global Benchmarking
NAFDAC has enhanced its vaccine regulatory system through institutional restructuring and international benchmarking. In 2024, the agency established a dedicated Directorate for Vaccines, Biologics, and Medical Devices, aligning Nigeria’s regulatory system with global best practices and bringing it up to par with advanced regulatory authorities around the world.
In 2022, NAFDAC achieved the World Health Organization (WHO) Maturity Level 3 (ML3) status for medicines and imported vaccines — a major milestone demonstrating that the country’s regulatory functions are well-defined, stable, and integrated. Current efforts are now focused on attaining ML3 for locally manufactured vaccines, a critical requirement for WHO prequalification.
Comprehensive Vaccine Oversight
NAFDAC’s regulatory capacity now covers the entire vaccine oversight process, including market authorization, clinical trial regulation, inspection, post-market surveillance, and pharmacovigilance. The agency 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 a robust system.
To ensure preparedness for future health emergencies, NAFDAC has developed national guidelines for emergency response and continues to enhance regulatory readiness. The agency is also encouraging local manufacturers to begin “fill and finish” operations as an important step toward full-scale domestic vaccine production.
Commitment to Local Manufacturing
Prof. Adeyeye stated that the strengthened regulatory framework, combined with the Federal Government’s commitment under the Renewed Hope Agenda, provides a strong foundation for sustainable vaccine manufacturing in Nigeria. She reaffirmed that NAFDAC remains dedicated to supporting manufacturers and ensuring that all locally produced vaccines meet international standards of safety, quality, and efficacy.
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