By Joyce Eyaba, JKNewsMedia Reporter
NIGERIA’s DRUG regulator, the National Agency for Food and Drug Administration and Control (NAFDAC) has secured full membership of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), the Agency announced.
NAFDAC in a press statement noted that the ICH is a select body comprising leading regulatory authorities and the pharmaceutical industry, dedicated to advancing scientific and technical principles of pharmaceutical development and developing harmonised technical guidelines to safeguard public health.
It stated that its journey to full membership began in the last quarter of 2022 when the Director-General, Prof. Mojisola Adeyeye was advised to apply for Observership status.
The Agency said it submitted an application, received approval, and was invited to the 2023 ICH meeting in Vancouver, Canada, where it delivered a formal presentation as part of the evaluation process, adding that it was subsequently granted Observership and given a set of membership requirements.
Over the following two years, NAFDAC said it undertook capacity-building activities, including training on multiple ICH guidelines and active participation in Expert Working Groups, as part of the membership pathway, noting that these steps formed the foundation of the rigorous membership process.
Also, the Agency confirmed it met the necessary requirements in April 2025 after convening an international workshop on ICH M13A (Bioequivalence) that brought together stakeholders in Lagos, including manufacturers, and engaged virtually with heads of regional regulatory agencies.
It also described its approach as methodical and structured and acknowledged support from Northeastern University, Boston, and the Bill & Melinda Gates Foundation for the training programmes, saying the Assembly of the ICH made the pronouncement at an in-person meeting on 18-19 November 2025 in Singapore, and that the ICH issued an official press release on 26 November 2025 on its website.
NAFDAC also stated that the achievement places Nigeria among global leaders committed to quality, safety, and efficacy of medicines, and that it means better access to high-quality medical products for citizens and improved competitiveness and confidence for Nigerian pharmaceutical manufacturers.
The release notes that there are 194 regulatory agencies globally and that Nigeria is now the 24th among a select group of 25 national regulatory authorities currently committed to implementing globally harmonised, science-based regulatory standards through ICH membership.
It said the development represents a major step forward in strengthening the quality, safety, and efficacy of medicines available to the population and added that the news was shared with H.E. Omayuli Francisca Kemi, the Ambassador of Nigeria to Singapore, who welcomed the NAFDAC team to Singapore.
Furthermore, NAFDAC outlined that full membership will enable it to shape and implement harmonised technical guidelines, improve regulatory efficiency, access scientific training and collaboration, support local manufacturers, and reinforce Nigeria’s role as a regulatory partner within Africa and support the African Medicines Agency vision, the press release said.
The Agency credited its progress to the steady leadership of the DG, the technical drive of staff serving on ICH Expert Working Groups, and the international training efforts led by the Director of Veterinary Medicine and Allied Products.
It also conveyed appreciation to Nigeria’s President Bola Tinubu, the Minister of Health and Social Welfare, development partners at home and abroad, and Nigerians whose support continues to anchor its work, according to the statement.
