NAFDAC secures full membership of global ICH body after two-year review

Nigeria’s pharmaceutical regulatory system has recorded a major global breakthrough 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), following a rigorous two-year evaluation process.

The elevation from observer to full member status places Nigeria among a select group of just 25 national regulatory authorities worldwide that implement globally harmonised, science-based pharmaceutical standards. The milestone was formally announced during the ICH Assembly meeting held in Singapore and later published on the organisation’s website.

NAFDAC’s journey began in late 2022, when the Agency, under the leadership of Prof. Moji Adeyeye, its director general, was advised to apply for Observership. Its first major step was a formal presentation at the 2023 ICH meeting in Vancouver, Canada, which earned the Agency an Observer slot and a detailed pathway of requirements toward full membership.

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Over the next two years, NAFDAC embarked on intensive capacity-building programmes. Staff underwent training on multiple ICH guidelines, while the Agency actively contributed to Expert Working Groups, demonstrating competency in scientific review, regulatory harmonisation, and guideline implementation. A major turning point came in April 2025 when NAFDAC successfully hosted an international workshop on ICH M13A (Bioequivalence) in Lagos, bringing together manufacturers and senior regulatory officials across Africa. The workshop showcased Nigeria’s readiness to adopt harmonised global standards.

Support from partners, including Northeastern University, Boston, and the Bill & Melinda Gates Foundation, further strengthened the Agency’s ability to meet ICH’s demanding criteria.

With full membership now secured, Nigeria is poised for significant public health and economic gains. For patients, the adoption of harmonised technical guidelines will mean faster access to high-quality, innovative medicines. For pharmaceutical manufacturers, it opens doors to global markets, boosts investor confidence and positions Nigerian-made products to compete internationally.

Regulators say the achievement reaffirms Nigeria’s commitment to strengthening medicine quality, safety, and efficacy while advancing the objectives of the African Medicines Agency (AMA). It also elevates NAFDAC’s role as a strategic regulatory partner both regionally and globally.

Adeyeye praised the dedication of NAFDAC staff, many of whom serve in ICH Expert Working Groups, noting that their scientific contributions and professionalism demonstrate that Nigerian regulatory scientists can stand shoulder-to-shoulder with global experts.