The National Agency for Food and Drug Administration and Control (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 pronouncement was made by the Assembly of the International Council for Harmonisation at the in-person meeting which took place on November 18-19, 2025 in Singapore. The official announcement was later made through a Press Release by the ICH on November 26 on their website - https://ich.org/.

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is a select body comprising leading regulatory authorities and the pharmaceutical industry. It is 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 toward full ICH membership commenced in the last quarter of 2022, when the Director General was advised to apply for Observership status. Following the submission and approval of the application, NAFDAC was invited to participate in the 2023 ICH meeting in Vancouver, Canada, where the Agency delivered a formal presentation as part of the evaluation process. NAFDAC was subsequently granted Observership and provided with a set of membership requirements.

Over the next two years, the Agency undertook a series of capacity-building activities, including training on multiple ICH guidelines to demonstrate effective implementation, as well as active participation in Expert Working Groups. These steps formed the foundation of the rigorous membership pathway.

The Agency fulfilled the necessary requirements in April 2025 following the successful international workshop on ICH M13A (Bioequivalence), during which NAFDAC convened stakeholders in Lagos—including manufacturers—and engaged virtually with Heads of regional regulatory agencies.

According to NAFDAC in a statement issued on Friday, December 5, “Our methodical and structured approach to meeting the criteria was central to this achievement. In addition, the support received from Northeastern University, Boston, USA, and the Bill & Melinda Gates Foundation for the training programs significantly contributed to the Agency’s attainment of ICH membership status.

“This achievement places Nigeria among global leaders committed to the highest standards of quality, safety, and efficacy of medicines. For our citizens, it means better access to high-quality medical products. For our pharmaceutical manufacturers, it opens the door to improved competitiveness and greater confidence in Nigerian-made products at home and abroad.

“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. To be part of the 25 NRAs is significant and for our country, it represents a major step forward in strengthening the quality, safety, and efficacy of medicines available to our population.

“The good news was shared with our H.E. Omayuli Francisca Kemi, the Ambassador of Nigeria to Singapore who warmly welcomed the NAFDAC Team to Singapore.”

NAFDAC in the statement signed by the DG, Prof. Adeyeye, noted what the feat 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, leading to better regulatory decisions and improved public health outcomes.

2. Improved Access to High-Quality Medicines

Patients in Nigeria will benefit from faster access to innovative, life-saving therapies, as alignment with ICH standards enhances regulatory efficiency and builds international confidence in our systems.

3. Enhanced Capacity and Technical Expertise

Membership provides Nigeria with access to cutting-edge scientific knowledge, training, and collaboration opportunities, strengthening NAFDAC’s technical workforce and institutional capacity.

4. Increased Confidence in Nigerian Pharmaceutical Products and Attraction for Foreign Investment

Our local manufacturers stand to benefit significantly from this development. Adoption of ICH guidelines improves product quality, boosts competitiveness, and facilitates partnership with multi-national companies and entry into regional and global markets.

5. Stronger Global Partnerships

Full membership reinforces Nigeria’s position as a strategic regulatory partner within Africa, contributing to stronger regional collaboration and supporting the African Medicines Agency (AMA) vision.

Continuing the Agency said in the statement: “This achievement did not happen overnight. It is the result of years of sustained commitment, leadership under the Director General, Prof Moji Adeyeye, and technical excellence across the Agency.

We proudly acknowledge the dedicated NAFDAC staff who have served — and continue to serve — as members of the ICH Expert Working Groups (EWGs). Their rigorous scientific input, countless hours of document review, expert contributions, and unwavering professionalism helped demonstrate that Nigeria possesses the competence and systems required of an ICH member. Planning of the international trainings was facilitated by the current Director of Veterinary Medicine and Allied Products who was previously in Drug Evaluation and Research Directorate.

“The efforts of the staff have brought prestige not only to NAFDAC but also to the Federal Republic of Nigeria who in its wisdom extended the tenure of the Director General for sustainability of the achievements during her first term as part of the Renewed Hope Agenda. This shows that Nigerian regulatory scientists can stand shoulder-to-shoulder with global experts, influencing standards that protect billions of people.”

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