Nigeria has recorded a major milestone in global pharmaceutical regulation as the National Agency for Food and Drug Administration and Control (NAFDAC) has secured full membership of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
The development elevates Nigeria into an exclusive league of national regulators recognised for implementing globally harmonised, science-driven standards.
This was contained in a statement signed by the Director General of NAFDAC, Prof Mojisola Adeyeye.
The statement reads partly: “The National Agency for Food and Drug Administration and Control (NAFDAC) is pleased to announce a historic milestone in Nigeria’s regulatory space: NAFDAC has officially been admitted into full membership of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) from an Observer status.”
“The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is a select body comprising leading regulatory authorities and the pharmaceutical industry. It is dedicated to advancing the scientific and technical principles of pharmaceutical development.”
“NAFDAC’s journey toward full ICH membership commenced in the last quarter of 2022, when the Director General was advised to apply for Observership status. Following the submission and approval of the application, NAFDAC was invited to participate in the 2023 ICH meeting in Vancouver, Canada, where the Agency delivered a formal presentation as part of the evaluation process.”
“Over the next two years, the Agency undertook a series of capacity-building activities, including training on multiple ICH guidelines to demonstrate effective implementation, as well as active participation in Expert Working Groups. These steps formed the foundation of the rigorous membership pathway.”
According to the statement, NAFDAC fulfilled all membership requirements in April 2025, following an international workshop on ICH M13A (Bioequivalence) held in Lagos, which brought together manufacturers and regional regulatory leaders. The Agency acknowledged support from Northeastern University, Boston, and the Bill & Melinda Gates Foundation for training programmes that strengthened its technical readiness.
The formal pronouncement admitting Nigeria as a full ICH member was made at the Council’s Assembly meeting held in Singapore on 18–19 November 2025. A follow-up press release was published on the ICH website on 26 November 2025.
NAFDAC said the achievement positions Nigeria among a select group of just 25 national regulatory authorities globally committed to implementing harmonised scientific standards for pharmaceutical regulation—out of 194 worldwide.
The Agency described the feat as a transformative advance for Nigeria’s public health system, pharmaceutical industry and global competitiveness.
The regulator noted that full ICH membership will enable Nigeria to implement global standards in the regulation of medicines, improve access to high-quality therapies, expand technical capacity, attract foreign investment, and strengthen Nigeria’s role as a strategic regulatory partner in Africa. It added that the development also aligns with the broader continental goal of supporting the African Medicines Agency (AMA).
Prof Adeyeye credited the achievement to years of institutional commitment, technical excellence and the dedication of NAFDAC staff who served on various ICH Expert Working Groups. She said their contributions demonstrated that Nigeria possesses the regulatory competence expected of global standard-setters.
The statement also noted that the Federal Government’s extension of the DG’s tenure contributed to sustaining momentum under the Renewed Hope Agenda.
NAFDAC reaffirmed its commitment to the full and consistent implementation of ICH guidelines, strengthening Nigeria’s regulatory ecosystem and supporting local pharmaceutical innovation and manufacturing.
It emphasised that the Agency remains dedicated to transparency, scientific integrity and safeguarding public health through international collaboration.
Prof Adeyeye described the membership as a proud moment for Nigeria, expressing gratitude to President Bola Ahmed Tinubu, the Minister of Health and Social Welfare, international partners and the Nigerian public for their continued support.
