Nigeria joins global drug-regulation body ICH

By Kunle Sanni –

Nigeria has secured a place among the world’s leading drug-regulation authorities following the admission of the National Agency for Food and Drug Administration and Control (NAFDAC) into the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).

The confirmation was made during the ICH Assembly held in Singapore from 18 to 19 November 2025, marking the council’s second in-person meeting of the year. South Africa’s Health Products Regulatory Authority (SAHPRA) was also admitted as a full member at the same session, while DIGEMAPS of the Dominican Republic and the Philippine FDA were granted observer status.

With the latest admissions, the 35-year-old ICH now comprises 25 members and 41 observers.

To qualify for membership, national regulatory agencies must demonstrate the implementation of at least three core Tier 1 ICH guidelines—covering stability testing (Q1), good manufacturing practice for active pharmaceutical ingredients (Q7), and good clinical practice (E6). They must also participate in biannual ICH meetings and present a structured plan to adopt all ICH guidelines.

ICH serves as a global platform where regulators and the pharmaceutical industry collaborate on scientific and technical standards for drug development. The organisation develops harmonised requirements aimed at ensuring that medicines around the world are safe, effective and of consistently high quality.