Nigeria has recorded a major milestone in pharmaceutical regulation as the National Agency for Food and Drug Administration and Control has secured full membership of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.
The development, announced at the ICH Assembly held in Singapore between 18 and 19 November, marks NAFDAC’s elevation from Observer to full voting member of the highly selective global body.
In a statement on Friday, the Director-General of NAFDAC, Prof. Mojisola Adeyeye, described the achievement as “historic,” noting that the upgrade places Nigeria among countries committed to the highest standards of medicine quality, safety and efficacy.
She said the membership would improve access to high-quality medical products for Nigerians while boosting the competitiveness of locally produced pharmaceuticals at home and internationally.
Adeyeye explained that NAFDAC’s journey began in 2022 when the agency was advised to seek Observer status.
After a presentation at the 2023 ICH meeting in Vancouver, Observership was granted, followed by a two-year period of intensive capacity-building, training on ICH guidelines and active contribution to Expert Working Groups.
She credited the success to a “methodical and structured approach” supported by Northeastern University, Boston, and the Bill & Melinda Gates Foundation.
The agency fulfilled all membership criteria in April 2025, following its hosting of a major international workshop on ICH M13A (Bioequivalence) in Lagos, which brought together local manufacturers and regulatory experts from across the region.
With its admission, Nigeria becomes the 24th of only 25 national regulatory authorities globally recognised for implementing harmonised, science-driven regulatory standards.
According to NAFDAC, the new status will quicken access to innovative, life-saving therapies for Nigerian patients and strengthen regional regulatory integration, especially under the African Medicines Agency framework.
Adeyeye praised the agency’s staff for their contributions to ICH working groups and thanked the Federal Government for sustaining institutional reforms.
She reaffirmed NAFDAC’s commitment to transparency, scientific integrity and the full implementation of ICH guidelines.
