NAFDAC has secured full membership of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, joining an elite circle of the world’s top drug regulatory authorities.
The announcement was made at the ICH Assembly held in Singapore between November 18 and 19, 2025, and later published on the organisation’s website on November 26, marking Nigeria’s transition from observer to full member.
Director General Prof Mojisola Adeyeye described the development as historic, saying it places Nigeria among global leaders committed to the highest standards of quality, safety and efficacy for medicines.
She said the achievement will give Nigerians better access to high quality medical products and boost the competitiveness and credibility of Nigerian made medicines in local and international markets.
NAFDAC began its journey toward ICH membership in late 2022, first applying for observer status and earning it after a presentation at the 2023 ICH meeting in Vancouver, before being given rigorous membership conditions.
Over the next two years, the agency invested heavily in capacity building, including training on multiple ICH guidelines and active participation in Expert Working Groups, with support from Northeastern University in Boston and the Bill and Melinda Gates Foundation.
NAFDAC said it met all membership criteria in April 2025 after successfully hosting an international workshop on ICH M13A (bioequivalence) in Lagos that brought together local manufacturers and regional regulators.
With its admission, Nigeria becomes one of only about two dozen national regulatory authorities worldwide formally committed to applying harmonised, science based ICH standards.
Adeyeye noted that full membership will allow NAFDAC to help shape global technical guidelines, gain access to advanced scientific knowledge and training, and further strengthen its regulatory workforce.
The agency expects Nigerian pharmaceutical companies to benefit through improved product quality, stronger international partnerships, better market access and a bigger role in African regulatory integration and the African Medicines Agency initiative.
NAFDAC said it remains committed to fully implementing ICH guidelines, deepening regulatory reforms and safeguarding public health in line with President Bola Tinubu’s Renewed Hope Agenda.
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