Nigeria has been admitted as a full member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), marking a major step forward for the country’s regulatory system.
The National Agency for Food and Drug Administration and Control (NAFDAC) secured membership during the ICH Assembly held in Singapore from November 18 to 19, 2025. It was the council’s second in-person meeting of the year.
South Africa’s Health Products Regulatory Authority (SAHPRA) was also admitted as a member, while DIGEMAPS of the Dominican Republic and the Philippine Food and Drug Administration were granted Observer status.
Founded 35 years ago, the ICH now comprises 25 Members and 41 Observers.
To qualify for membership, national regulatory authorities must implement at least three Tier 1 ICH Guidelines — the Q1 Stability Testing guideline, Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, and E6 Good Clinical Practice guideline. They must also participate in biannual ICH meetings and present a plan for adopting all ICH guidelines.
The ICH serves as a global platform for regulators and the pharmaceutical industry to harmonise scientific and technical standards, ensuring the development and registration of safe, effective and high-quality medicines for human use.
