The National Agency for Food and Drug Administration and Control has secured full membership in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, placing Nigeria among a select group of global medicines regulators.
The admission was approved during the ICH Assembly’s in-person meeting held Nov. 18–19 in Singapore and announced by the council on Nov. 26.
NAFDAC moved from observer to full member after completing a two-year evaluation process that included capacity-building, implementation of multiple ICH guidelines and participation in expert working groups. The agency met the final requirements in April following an international workshop on bioequivalence it hosted in Lagos.
Nigeria now becomes the 24th national regulatory authority—and one of only 25 globally—committed to harmonised, science-based pharmaceutical standards under the ICH framework.
What It Means for Nigeria
According to NAFDAC, full membership will strengthen the country’s regulation of medicines by aligning processes with global standards. The agency said patients will benefit from improved access to high-quality and innovative therapies as regulatory decisions become faster and more efficient.
The new status also provides access to advanced scientific knowledge and training, boosting NAFDAC’s technical capacity. Local drug manufacturers are expected to gain from increased credibility and competitiveness, making it easier to enter regional and international markets and attract foreign investment.
NAFDAC added that the development enhances Nigeria’s standing as a regulatory partner in Africa and supports ongoing collaboration under the African Medicines Agency.
The agency credited the milestone to sustained reforms, technical contributions from its staff in ICH working groups and support from international partners.
