KEY POINTS
- NAFDAC ICH membership boosts Nigeria’s global regulatory standing.
- NAFDAC ICH membership strengthens access to quality medicines.
- NAFDAC ICH membership accelerates pharmaceutical innovation locally.
The International Council for Harmonisation has accepted Nigeria’s National Agency for Food and Drug Administration and Control as a full member.
This makes Nigeria one of the best pharmaceutical regulators in the world. The declaration was made at the ICH Assembly in Singapore, making Nigeria the 24th national regulatory authority to obtain this title.
NAFDAC ICH membership marks global regulatory breakthrough
NAFDAC Director General Moji Adeyeye called the milestone historic for Nigeria and Africa, saying it affirms the agency’s scientific capacity and global relevance.
She noted that full membership will expand access to high-quality, safe and effective medicines while integrating Nigeria more deeply into the global pharmaceutical ecosystem. “Our regulatory scientists now stand shoulder-to-shoulder with the best in the world,” she said.
The agency began its push for membership after securing observer status in 2022. It took part in the 2023 Assembly in Vancouver and also spent two years improving its skills by going to training sessions, reviewing guidelines, and working on several Expert Working Groups.
The April 2025 international workshop in Lagos on the ICH M13A bioequivalence guideline was a big deal. It brought together regulators and producers from all over Africa.
Capacity building is what makes the membership work
Moreover, Adeyeye credited the structured approach behind the achievement, supported by Northeastern University in Boston and the Bill & Melinda Gates Foundation. Nigeria’s Ambassador to Singapore, Omayuli Francisca Kemi, praised the team during the Assembly, describing the development as a national moment of pride.
Furthermore, full membership enables NAFDAC to contribute directly to global guideline development and apply harmonised standards locally to improve regulatory decision-making. Officials further say this will speed up access to innovative therapies, enhance domestic manufacturing quality and attract new investment into Nigeria’s pharmaceutical industry.
Adeyeye also said that the systematic approach that led to the success was supported by the Bill & Melinda Gates Foundation and Northeastern University in Boston.
NAFDAC said it remains committed to full implementation of ICH guidelines and to strengthening Nigeria’s regulatory environment. The agency further expressed appreciation to President Bola Ahmed Tinubu, the Ministry of Health, partners and citizens for their support.
