The National Agency for Food and Drug Administration and Control (NAFDAC) has obeen 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 of Technical Requirements for Pharmaceuticals for Human Use (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 full membership process of the ICH started in the last quarter of 2022, when the Director -General was advised to apply for Observership status and the agency was subsequently granted Observership and provided with a set of membership requirements.
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Over the following 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 all of which formed the foundation of the rigorous membership pathway.
It 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.
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.
The admission of the agency was confirmed by the Assembly of the International Council for Harmonisation at the in- person meeting which took place on 18-19 November 2025 in Singapore, and later through a statement by the Council.
The full membership of the ICH by NAFDAC places Nigeria among global leaders committed to the highest standards of quality, safety, and efficacy of medicines, and for Nigerians, 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 the country, it represents a major step forward in strengthening the quality, safety, and efficacy of medicines available to our population.
The full membership of the IHC 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; and 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.
Also, the membership provides Nigeria with access to cutting-edge scientific knowledge, training, and collaboration opportunities, strengthening NAFDAC’s technical workforce and institutional capacity.
In addition, Nigeria’s 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; just as the new status reinforces Nigeria’s position as a strategic regulatory partner within Africa, contributing to stronger regional collaboration and supporting the African Medicines Agency (AMA) vision.
Experts have commended the Director-General of the agency, Prof. Mojisola Adeyeye and the management staff who have served and will continue to serve as members of the ICH Expert Working Groups (EWGs).
They noted that their 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.
As a full ICH member, NAFDAC restated its commitment to the full and consistent implementation of ICH guidelines, strengthening Nigeria’s regulatory ecosystem, supporting local pharmaceutical innovation and manufacturing, maintaining the highest levels of transparency, integrity, and science-based decision making, demonstrating its readiness to safeguarding the health of the nation
Photo Caption
L-R: Chairman of ICH, Dr. Gabriela Zenhausern, Director-General NAFDAC, Prof Mojisola Adeyeye, and ICH Vice-Chairman, Mr. Jeffrey Skene, at the Assembly of the International Council for the Harmonisation meeting in Singapore
