The National Agency for Food and Drug Administration and Control (NAFDAC) has said it is poised to attain the World Health Organization (WHO) Maturity Level Four (ML4) through the modernization of its regulatory system.
The Director-General of NAFDAC, Prof. Mojisola Adeyeye, made this known on Wednesday at a media parley in Lagos.
Adeyeye explained that the parley was organized to outline the agency’s roadmap for modernizing its regulatory system, a process that began in 2018.
The WHO Maturity Level Four (ML4) designation signifies a National Regulatory Authority (NRA) operating at the highest level of performance, characterized by advanced regulatory systems, robust processes and a strong commitment to continuous improvement.
NAFDAC attained WHO Maturity Level Three (ML3) status for medicines regulation in 2022 and was successfully re-benchmarked in 2025, making it the first regulatory authority in Africa to achieve the feat.
The director-general said the agency remains firmly committed to continuous improvement as it works towards attaining WHO ML4 status and designation as a WHO-Listed Authority (WLA).
According to her, NAFDAC has over the years adopted regulatory reliance and regional harmonization mechanisms, recognizing the need for efficiency in an increasingly complex regulatory environment.
Adeyeye added that the agency successfully underwent formal WHO benchmarking of medical devices regulation in 2024, thereby expanding its regulatory maturity beyond medicines and strengthening oversight of an increasingly important product category.
She, however, noted that the journey towards attaining WHO ML4 would be demanding, requiring sustained regulatory activities, enhanced safety monitoring, strengthened local manufacturing, adequate funding and the deployment of technology-driven systems.
“We are determined to attain WHO ML4 because we are driven by our mandate to safeguard the health of Nigerians,” she said.
Adeyeye noted that NAFDAC’s trajectory towards compliance with international standards, including ISO 9001:2015 certification, WHO ML3 status and successful ML3 re-benchmarking, has been recognized by leading National Regulatory Authorities worldwide.
She disclosed that this recognition led to NAFDAC’s admission as the 24th member of the International Council for Harmonization (ICH) in November 2025 in Singapore.
“This achievement is significant, considering that there are 194 National Regulatory Authorities globally, while the ICH comprises only 25 member authorities,” she said.
Adeyeye also commended President Bola Tinubu for removing NAFDAC from the list of revenue-generating agencies, noting that the decision would enable the agency to focus more effectively on its core regulatory responsibilities.
