The National Agency for Food and Drug Administration and Control (NAFDAC) has attained full membership of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), marking one of the most significant advancements in the nation’s pharmaceutical regulatory history.
The confirmation was made during the ICH Assembly held 18 and 19 November in Singapore. This development has made Nigeria the 24th national regulatory authority and one of only 25 worldwide to attain full ICH membership.
The Director General of NAFDAC, Prof. Mojisola Adeyeye, in a press statement described the achievement as a transformational moment for the country. “This is not just a recognition for NAFDAC; it is a recognition for Nigeria,” she said.
“Full ICH membership places us at the same table with the world’s most advanced regulatory agencies, and it shows that our systems, our scientists, and our processes meet the highest global standards.”
She added that the milestone reflects the country’s growing commitment to science-driven regulation. “For the Nigerian patient, this means better access to quality medicines. For our industries, it means improved competitiveness. For the world, it means Nigeria is ready to contribute meaningfully to global regulatory science,” Adeyeye said.
Plans towards attaining full membership began in 2022 when the agency applied for Observership status. After a successful presentation at the 2023 ICH meeting in Vancouver, NAFDAC received Observership and was guided towards full membership.
NAFDAC, since 2023 intensified its capacity-building efforts such as training staff on multiple ICH guidelines, participating in expert working groups, and implementing global best practices.
A key milestone was reached in April 2025 when the agency organised an international workshop in Lagos on ICH M13A (Bioequivalence), where local manufacturers and regional regulatory heads were convened to demonstrate Nigeria’s growing technical capacity.
Prof. Adeyeye credited the role of international partners in the agency’s progress while expecting that the new status will boost confidence in Nigeria’s regulatory decisions and enable faster access to high-quality medicines. The DG emphasised that the benefits will be far-reaching. “With ICH membership, we now operate with globally harmonised scientific guidelines,” Adeyeye explained.
The NAFDAC boss acknowledged the contributions of its staff, particularly those serving in ICH Expert Working Groups. “Our staff worked tirelessly, reviewing documents, participating in scientific discussions, and demonstrating professionalism at the highest level,” Adeyeye said.
She ended with a reaffirmation that the agency is still committed to safeguarding public health, a responsibility now emphasised with the new status of full ICH member.
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