NAFDAC retains WHO Maturity Level 3 status in regulation of medicines, vaccines
The World Health Organization (WHO) has confirmed that Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC) has achieved and maintained Maturity Level 3 (ML3) status for the regulation of medicines and imported vaccines.
The confirmation came after the successful completion of a re-benchmarking exercise, which evaluated the country’s national regulatory system from 28 to 30 May 2025.
The assessment was conducted by the WHO Regulatory Systems Strengthening Team in collaboration with the WHO Regional Office for Africa and the WHO Country Office in Nigeria.
NAFDAC first attained ML3 status in 2022, making it the first National Regulatory Authority in Africa to do so. In line with WHO policy, periodic reviews are conducted to ensure that this status is maintained. A formal re-benchmarking took place in November 2024, followed by five Institutional Development Plan (IDP) review meetings between February and April 2025 to assess progress on corrective actions.
In a letter to NAFDAC’s Director-General, Prof. Mojisola Adeyeye, WHO’s Assistant Director-General, Dr. Yukiko Nakatani, stated that the agency successfully closed all critical recommendations and continues to operate a stable, well-functioning, and integrated regulatory framework.
Dr. Nakatani commended the Government of Nigeria for its investments in strengthening the regulatory system, noting that the achievement reaffirms the country’s commitment to universal health coverage and the Sustainable Development Goals.
She added that the accomplishment should promote confidence and trust in Nigeria’s regulatory processes, while encouraging greater reliance on its authority from both local and international stakeholders.
According to WHO, periodic confirmation of NAFDAC’s functionality will continue, with a follow-up visit scheduled within a year and another re-benchmarking in four years to assess sustainability and address any emerging challenges.
