NAFDAC Achieves Full Membership of the International Council for Harmonisation (ICH)

The National Agency for Food and Drug Administration and Control (NAFDAC) has announced a historic milestone: NAFDAC has officially been admitted into full membership of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) from an Observer status.

The International Council for Harmonisation (ICH) is a select body comprising leading regulatory authorities and the pharmaceutical industry, dedicated to advancing the scientific and technical principles of pharmaceutical development. Through the development of harmonised technical guidelines, the ICH safeguards public health by ensuring the availability of safe, effective, and high-quality medicines worldwide.

NAFDAC's Journey to Full Membership:

• Application for Observership status commenced in Q4 2022
• Granted Observership after presentation at 2023 ICH meeting in Vancouver, Canada
• Two years of capacity-building activities and training on ICH guidelines
• Active participation in Expert Working Groups
• Successful international workshop on ICH M13A (Bioequivalence) in April 2025
• Official announcement made at ICH meeting in Singapore, November 18-19, 2025

This achievement places Nigeria among global leaders committed to the highest standards of quality, safety, and efficacy of medicines. There are 194 regulatory agencies globally, and Nigeria is now the 24th among the select group of 25 national regulatory authorities (NRAs) worldwide currently committed to implementing globally harmonised, science-based regulatory standards through ICH membership.

What This Means for Nigeria:

1. Regulation of Medicines using Global Standards - Full membership empowers NAFDAC to actively shape and implement harmonised technical guidelines that match international best practices.

2. Improved Access to High-Quality Medicines - Patients in Nigeria will benefit from faster access to innovative, life-saving therapies.

3. Enhanced Capacity and Technical Expertise - Membership provides access to cutting-edge scientific knowledge, training, and collaboration opportunities.

4. Increased Confidence in Nigerian Pharmaceutical Products - Local manufacturers benefit from improved product quality, boosted competitiveness, and facilitated entry into regional and global markets.

5. Stronger Global Partnerships - Full membership reinforces Nigeria's position as a strategic regulatory partner within Africa, supporting the African Medicines Agency (AMA) vision.

This achievement is the result of years of sustained commitment and leadership under Director General Prof. Moji Adeyeye, with support from Northeastern University, Boston, USA, and the Bill & Melinda Gates Foundation.