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NAFDAC becomes the 24th member of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use

Photo L to R: Ms. Lenita Lindstrom (Assembly Chair – EC, Europe); Prof. Mojisola Adeyeye (NAFDAC, Nigeria); Dr. Gabriela Zenhausen (Assembly Vice-Chair – Swissmedic, Switzerland)

The National Agency for Food and Drug Administration and Control (NAFDAC), Nigeria, has officially been admitted as a Member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).

The confirmation was made during the 51st ICH Assembly held in person on 18–19 November 2025 in Singapore. Alongside NAFDAC, the South African Health Products Regulatory Authority (SAHPRA) was also welcomed as a new Member. Additionally, DIGEMAPS of the Dominican Republic and the Philippine Food and Drug Administration (FDA) joined as Observers.

With this development, ICH now has a total of 25 Members and 41 Observers worldwide.

ICH Membership for national regulatory authorities requires implementation of at least the three Tier 1 ICH Guidelines – Q1 (Stability Testing), Q7 (GMP for Active Pharmaceutical Ingredients), and E6 (GCP) – as well as regular participation in ICH meetings and a clear plan to implement all ICH Guidelines.

NAFDAC’s admission reflects the Agency’s continued commitment to international regulatory alignment, pharmaceutical quality, safety, and efficacy standards.

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