Nigeria has recorded a major milestone in pharmaceutical regulation as the National Agency for Food and Drug Administration and Control (NAFDAC) has been admitted as a full member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
The development, announced at the ICH Assembly held between November 18 and 19, 2025, in Singapore, and later published on the organisation’s website on November 26, marks Nigeria’s transition from Observer to full member of the influential global regulatory body.
In a statement issued on Friday, the Director-General of NAFDAC, Prof. Mojisola Adeyeye, described the feat as “historic”, noting that the admission places Nigeria among a select group of 25 national regulatory authorities committed to harmonised, science-based pharmaceutical standards.
“This accomplishment places Nigeria among global leaders committed to the highest standards of quality, safety, and efficacy of medicines,” Adeyeye said. “For our citizens, it means better access to high-quality medical products. For our pharmaceutical manufacturers, it opens the door to improved competitiveness and greater confidence in Nigerian-made products at home and abroad.”
Adeyeye recalled that the journey to ICH membership began in late 2022 when NAFDAC was encouraged to apply for Observer status.
“Following our presentation at the 2023 ICH meeting in Vancouver, we were granted Observership and provided with rigorous membership requirements,” she noted.
Over the next two years, the agency intensified capacity-building efforts, including extensive training on ICH guidelines and active participation in Expert Working Groups.
“The methodical and structured approach we adopted was central to this achievement,” Adeyeye stated, acknowledging the support of Northeastern University, Boston, and the Bill & Melinda Gates Foundation for key training programmes.
NAFDAC said it met all membership obligations in April 2025 after successfully hosting an international workshop on ICH M13A (Bioequivalence) in Lagos, which brought together local manufacturers and regional regulatory leaders.
With its admission, Nigeria becomes the 24th national regulatory authority among only 25 regulators worldwide empowered to shape and implement harmonised pharmaceutical guidelines through the ICH framework.
The Nigerian Ambassador to Singapore, H.E. Omayuli Francisca Kemi, who received the NAFDAC delegation, praised the agency for “bringing Nigeria into an exclusive circle of global regulatory excellence.”
NAFDAC outlined multiple advantages of its new status, including the ability to contribute actively to global guideline development and access to advanced scientific knowledge and technical training.
According to the agency, full membership will ensure: Faster access to innovative, life-saving therapies due to improved global confidence in Nigeria’s regulatory systems, Strengthened technical capacity of NAFDAC’s workforce through enhanced scientific collaboration, Better product quality and competitiveness for Nigerian pharmaceutical companies, alongside increased foreign investment and partnerships, Support for regional regulatory integration, including the African Medicines Agency initiative.
Adeyeye commended NAFDAC scientists serving in ICH Expert Working Groups, saying their work demonstrated that “Nigerian regulatory scientists can stand shoulder-to-shoulder with global experts.”
She also expressed gratitude to the Federal Government for extending her tenure, noting that the continuity “ensured sustainability of achievements under the Renewed Hope Agenda.”
NAFDAC reiterated its commitment to fully implementing ICH guidelines, supporting pharmaceutical innovation, and enhancing transparency in regulatory processes.
“This is a proud moment for NAFDAC, for Nigeria under the Renewed Hope Agenda of the President, and for Africa,” Adeyeye said. “We will continue to safeguard public health, now reinforced with the full strength and collaboration of the ICH global community.”
The agency thanked President Bola Tinubu, the Minister of Health and Social Welfare, and international partners for their support throughout the membership process.
