Nigeria’s health regulatory system has recorded a global breakthrough with far-reaching implications for medicine quality, access, and industry competitiveness following the full admission of the National Agency for Food and Drug Administration and Control (NAFDAC) into the International Council for Harmonisation (ICH) of Technical Requirements for Pharmaceuticals for Human Use.
NAFDAC’s elevation was formally endorsed at the ICH Assembly meeting held in Singapore on November 18 and 19, and subsequently affirmed in a public statement issued by ICH on November 26.
The upgrade from observer to full member places Nigeria among the world’s most advanced regulatory systems, with NAFDAC now able to contribute directly to global standard-setting while aligning local pharmaceutical manufacturing with internationally accepted best practices.
With the elevation, Nigeria joins just 25 regulatory authorities worldwide participating fully in the development and implementation of harmonised scientific guidelines, marking a major leap for the country’s pharmaceutical governance and industry competitiveness.
Out of 194 regulators globally, this elevation sets Nigeria apart and strengthens its leadership role in Africa, the agency’s Director General (DG) Prof Mojisola Adeyeye said, adding that the transition means stronger assurance of safe, high-quality, and effective medicines.
Local patients will benefit from quicker access to innovative therapies because ICH alignment improves regulatory efficiency and strengthens the credibility of approvals, she noted.
Additionally, she noted that for pharmaceutical manufacturers, full membership opens the door to expanded regional and global markets, deeper collaborations with multinational firms, and increased foreign investment confidence.
The DG, in a statement on Friday, recalled that the pathway to this achievement began in late 2022 when NAFDAC was encouraged to apply for observer status.
According to her, the application was successful, and the agency participated in the 2023 ICH meeting in Vancouver, where it made a formal presentation.
She, however, explained that observership came with a list of requirements, setting the stage for a series of capacity-building activities that demonstrated NAFDAC’s technical competence.
Noting that over the next two years, NAFDAC received training on multiple guidelines and played active roles in expert working groups, Adeyeye said a decisive milestone was reached in April 2025 following an international ICH M13A workshop hosted in Lagos.
She said the event brought together manufacturers and connected virtually with heads of regulatory agencies across the region, adding that Northeastern University in Boston and the Bill and Melinda Gates Foundation provided crucial technical support for the training programmes that strengthened NAFDAC’s compliance capacity.
She attributed NAFDAC’s success to sustained leadership, structured planning, and the technical expertise of its staff, who contributed to expert working groups, participated in scientific reviews, and delivered high-value regulatory input.
She stressed that the agency noted that its teams demonstrated the competence expected of members, setting standards that protect public health globally.
The DG affirmed that full membership reinforces Nigeria’s commitment to implementing ICH guidelines, supporting pharmaceutical innovation, strengthening local regulation, and promoting transparency and science-based decisions.
It also advances the African Medicines Agency vision and enhances Nigeria’s role as a strategic partner within the continent, she noted, while pledging the agency’s determination to intensify efforts to safeguard public health with strengthened global collaboration.
