Home NewsNAFDAC targets WHO Maturity Level 4 with AI-driven reforms

NAFDAC targets WHO Maturity Level 4 with AI-driven reforms

by Haruna Gimba
0 comments

By Muhammad Amaan

The National Agency for Food and Drug Administration and Control (NAFDAC) said that it was poised to attain the World Health Organisation (WHO) Maturity Level Four.

The NAFDAC Director-General, Mojisola Adeyeye, who made this known at a media parley on Wednesday, said the agency aimed to attain the feat through modernisation of its regulatory system.

She said that the parley was organised to outline the agency’s roadmap to modernising its regulatory system that started in 2018.

The WHO Maturity Level 4 (ML4) signified a National Regulatory Authority (NRA) operating at the highest level of performance, characterised by advanced regulatory systems, robust processes, and a commitment to continuous improvement.

The agency attained WHO Maturity Level 3 status for medicines regulation in 2022 and was successfully re-benchmarked in 2025, making NAFDAC the first regulatory authority in Africa to achieve the feat.

Prof. Adeyeye said that NAFDAC remained firmly committed to continuous improvement as it aimed to advance to WHO ML4 and designation as a WHO-Listed Authority (WLA).

The director-general said that over the years, the agency had actively adopted regulatory reliance and regional harmonisation mechanism, highlighting that NAFDAC recognised the need for efficiency in an increasingly complex regulatory environment.

She added that the agency successfully underwent formal WHO benchmarking of medical devices regulation in 2024, expanding its regulatory maturity beyond medicines and strengthening oversight of an increasingly important product category.

She, however, noted that the journey to attain WHO ML4 would not be an easy task, adding that consistent regulatory activities, safety monitoring, strengthening of local manufacturing, funds, technology-driven system and more are required.

“We are going to get to WHO ML4 because we are driven by our mandate to safeguard the health of Nigerians,” she said.

The director-general said NAFDAC trajectory into compliance with international standards ISO 9001:2015, WHO ML3, and the successful ML3 Re-benchmarking was recognised by leading National Regulatory Authorities (NRAs).

Prof. Adeyeye added that the recognition led to the prestigious admission of NAFDAC as 24th member in the International Council for Harmonisation (ICH) in November 2025 in Singapore.

“This achievement is significant because there are 194 NRAs globally and ICH is comprised of only 25 member NRAs,” she said.

Adeyeye commended President Bola Tinubu for removing NAFDAC from the list of revenue generating agencies in the country, noting that it would aid the agency in carrying out major tasks.

Related Articles

Leave a Comment