(NAFDAC DG, Prof Mojisola Adeyeye, recording strings of successes for Nigeria)
By Anthony Isibor
THE World Health Organization, WHO, has announced that Nigeria’s National Agency for Food and Drug Administration and Control, NAFDAC, has successfully maintained Maturity Level 3, ML 3, in the regulation of medicines and vaccines (non-producing), marking a significant milestone in the country’s public health governance.
In an official letter to NAFDAC’s Director-General, Professor Mojisola Christianah Adeyeye, with reference number RSS-18-370-42AFRO RSS/AK/DM-cm, WHO’s Assistant Director-General, Yukiko Nakatani, confirmed that the recognition follows the completion of the final phase of the re-benchmarking process conducted between 28 and 30 May 2025.
The exercise was carried out in collaboration with the WHO Regional Office for Africa, WHO/AFRO, and the WHO Country Office in Nigeria.
The re-benchmarking is part of WHO’s Regulatory Systems Strengthening programme, which evaluates national agencies’ capacity to regulate medicines and vaccines effectively.
Nigeria’s formal re-benchmarking began in November 2024, with five follow-up meetings between February and April 2025 to track the implementation of corrective actions.
According to Nakatani, achieving and sustaining ML 3 means Nigeria now operates a “stable, well-functioning, and integrated framework” for regulating medicines and vaccines.
She credited the success to the Nigerian government’s investment in strengthening its regulatory system and emphasized that the milestone bolsters confidence, trust and international reliance on NAFDAC’s authority.
“This achievement reaffirms the collaboration between WHO and the Government of Nigeria towards realizing the targets of universal health coverage and the sustainable development goals,” Nakatani wrote, adding that periodic reviews will ensure the maturity level is sustained.
WHO plans follow-up visits within a year and a full re-benchmarking in four years.
ML 3 is a globally recognised status indicating a regulatory authority’s capability to ensure quality, safety and efficacy of medicines and vaccines through a robust, reliable system; a designation that places Nigeria among the leading regulators in Africa for non-producing countries.
This recognition further strengthens NAFDAC’s position in the global health space and enhances Nigeria’s capacity to attract partnerships, foster public health innovation and ensures the safety of medicines and vaccines for its population.
