By Maryanne Awuya
Nigeria has achieved a major milestone in global pharmaceutical regulation with the admission of the National Agency for Food and Drug Administration and Control (NAFDAC) as a full member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
The announcement was made at the recent ICH Assembly in Singapore, marking a historic leap that places Nigeria among only 25 national regulatory authorities worldwide recognized for meeting the council’s stringent global standards.
The NAFDAC Director-General, Prof. Mojisola Adeyeye, issued a statement on Friday describing the achievement as a historic breakthrough for both Nigeria and the entire African continent.
She said: “With this development, Nigeria becomes the 24th country to attain full ICH membership.”
According to her, the new status will significantly improve Nigerians’ access to high-quality, safe, and effective medicines.
“Full ICH membership means Nigerians will have better access to top-standard medicines. It shows our regulatory scientists can stand shoulder-to-shoulder with the best in the world.
“NAFDAC’s journey to full membership began in 2022 with its admission as an Observer, followed by active participation in ICH meetings, expert working groups, and extensive capacity-building on key ICH guidelines.
“The Agency completed all membership requirements in April 2025, supported by strategic partnerships with Northeastern University, Boston, and the Bill & Melinda Gates Foundation,” she said.
In the past two years, the agency underwent intensive capacity-building training on multiple ICH guidelines, participated in expert working groups, and hosted high-level technical sessions.
A significant milestone was the international workshop held in Lagos in April 2025.
The event focused on the ICH M13A guideline on Bioequivalence and brought together pharmaceutical manufacturers and regulators from across Africa.
Nigeria’s Ambassador to Singapore, H.E. Omayuli Francisca Kemi, who received the NAFDAC delegation during the Assembly, commended the agency’s achievement.
She added: “This is a moment of pride for Nigeria. NAFDAC has demonstrated leadership, resilience and expertise to earn a place on the global regulatory stage”.
With full ICH membership, NAFDAC now has the authority to contribute directly to the development of global pharmaceutical guidelines and implement them locally.
Adeyeye also commended members of NAFDAC’s Expert Working Groups for their “rigorous scientific input and countless hours of document review,” saying their work showed Nigeria’s readiness for global engagement.
She credited the Federal Government for supporting the agency, noting that the extension of her tenure ensured continuity during a crucial phase.
“We will continue to safeguard the health of the nation—now with the full strength of the ICH global community behind us,” she said.
NAFDAC expressed appreciation to President Bola Ahmed Tinubu, the Minister of Health and Social Welfare, international partners, and Nigerians for their support throughout the process.
The agency reaffirmed its commitment to fully implementing ICH guidelines, strengthening the country’s regulatory ecosystem, and supporting pharmaceutical innovation and local manufacturing.
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