NAFDAC secures full membership of global pharmaceutical standards body, ICH

Nigeria has recorded a major regulatory milestone 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 upgrade from Observer status places Nigeria among a select group of national regulatory authorities committed to implementing globally harmonised, science-based standards for medicines.

The announcement was made at the ICH Assembly during its in-person meeting held on 18–19 November 2025 in Singapore, and later published on the organisation’s website on 26 November 2025.

NAFDAC began its journey toward full membership in late 2022 after being advised to apply for Observership. Following approval of its application, the Agency participated in the 2023 ICH meeting in Vancouver, Canada, where it delivered a formal presentation as part of the evaluation process.

The Agency was subsequently granted Observership and provided with requirements for upgrading to full membership.

Over the next two years, NAFDAC undertook extensive capacity-building initiatives, including training on multiple ICH guidelines, active participation in Expert Working Groups, and demonstrating effective implementation of harmonised standards.

The Agency fulfilled all membership requirements in April 2025 after hosting an international workshop on ICH M13A (Bioequivalence) in Lagos, which brought together local manufacturers and heads of regional regulatory agencies.

The Agency acknowledged the support received from Northeastern University, Boston, and the Bill & Melinda Gates Foundation, which contributed significantly to training and technical readiness.

With Nigeria now listed among 25 national regulatory authorities globally aligned with ICH standards, the achievement is expected to enhance the quality, safety, and efficacy of medical products available in the country. It also boosts the competitiveness of Nigerian pharmaceutical manufacturers and strengthens prospects for international partnerships and investment.

NAFDAC noted that full membership will give Nigeria access to cutting-edge scientific knowledge and improved collaboration with global regulators, further reinforcing the country’s leadership role in Africa’s evolving pharmaceutical regulatory ecosystem.

The Director General, Prof. Moji Adeyeye, was commended for her leadership and for sustaining reforms supported under the Renewed Hope Agenda. NAFDAC also acknowledged Nigerian regulatory scientists serving in ICH Expert Working Groups, whose technical contributions were instrumental to the Agency’s admission.

The Agency reaffirmed its commitment to implementing ICH guidelines, strengthening the regulatory environment, supporting local pharmaceutical innovation, and upholding transparency and science-based decision-making.

NAFDAC expressed gratitude to President Bola Ahmed Tinubu, the Minister of Health and Social Welfare, international partners, and Nigerians for their continued support, pledging to continue safeguarding public health through strengthened global collaboration.