NAFDAC secures full membership in the international council for harmonisation
Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC) has achieved a historic feat by securing full membership of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
This remarkable achievement was formally announced during the recent ICH Assembly held in Singapore. The development represents a major leap forward in the nation’s regulatory advancement and places Nigeria on the global map of advanced drug control.
With this new status, Nigeria has become only the 24th country to achieve full membership out of a maximum of 25 National Regulatory Authorities (NRAs) worldwide. This exclusive recognition signifies NAFDAC’s demonstrated commitment to adhering to globally harmonized pharmaceutical standards. The rigorous process underscores the agency’s dedication to improving the quality and safety of medicines available to the Nigerian populace.
Achievement described as a breakthrough for nigeria and africa
NAFDAC’s Director General, Professor Moji Adeyeye, described the achievement as a “historic breakthrough for Nigeria and the African continent.” She emphasized the tangible benefits that full membership will deliver to ordinary Nigerians. The enhanced standing means citizens will now have better access to high-quality, safe, and effective medicines.
Professor Adeyeye further noted that the membership confirms that Nigeria’s regulatory scientists can now “stand shoulder-to-shoulder with the best in the world.” The elevation is expected to significantly bolster the country’s pharmaceutical sector and improve public health outcomes. This milestone is a testament to the sustained efforts and commitment demonstrated by the agency’s leadership and staff.
Rigorous two-year journey culminated in full ich status
NAFDAC began its dedicated journey toward full ICH membership in late 2022 after successfully securing Observer status within the organization. The rigorous process involved the agency’s active participation in global meetings, including the 2023 ICH assembly held in Vancouver, Canada. During that meeting, NAFDAC delivered a crucial formal presentation as part of the extensive evaluation process required for full membership consideration.
Over the subsequent two years, the agency engaged in intensive capacity-building activities, including comprehensive training programs focused on multiple ICH guidelines. NAFDAC also demonstrated its readiness by actively participating in various Expert Working Groups (EWGs). A pivotal event was the international workshop held in Lagos in April 2025, which focused specifically on the ICH M13A guideline on Bioequivalence, drawing participants from across the African continent.
International partnerships bolstered nafdac’s regulatory capacity
Professor Adeyeye credited the successful attainment of full membership to a “methodical and structured approach,” which was significantly boosted by international support. The assistance provided by Northeastern University in Boston and the Bill & Melinda Gates Foundation was acknowledged as instrumental in building the agency’s technical capacity. This support allowed NAFDAC to refine its operational and scientific standards to meet stringent international requirements.
Nigeria’s Ambassador to Singapore, H.E. Omayuli Francisca Kemi, received the NAFDAC team during the ICH Assembly and lauded the agency’s unwavering efforts. The Ambassador stated that this achievement is a “moment of pride for Nigeria,” demonstrating the nation’s leadership, resilience, and expertise on the global regulatory stage. The support received from the Federal Government for the continuation of the Director General’s tenure was also credited with ensuring necessary continuity during the critical assessment phase.
Expected impact on pharmaceutical sector and patient access
Full ICH membership grants NAFDAC the direct power to contribute to the development of international pharmaceutical guidelines, rather than merely adopting them. The agency can now apply these harmonized guidelines locally, significantly strengthening its decision-making processes regarding drug approval and monitoring. Furthermore, this international recognition is expected to bring several key benefits to the Nigerian market.
The membership is projected to speed up patient access to innovative therapies developed globally. It will also serve to improve the quality of locally manufactured medicines, pushing domestic pharmaceutical companies to adopt global best practices. Ultimately, this elevation is anticipated to enhance investor confidence in Nigeria’s pharmaceutical sector, potentially attracting foreign direct investment and boosting local production capacity.
Commitment to full implementation and future innovation
NAFDAC affirmed its commitment to the full implementation of all ICH guidelines, ensuring its regulatory ecosystem is robust and aligned with global standards. Professor Adeyeye acknowledged the members of NAFDAC’s Expert Working Groups for their “rigorous scientific input and countless hours of document review.” Their efforts, she stated, clearly demonstrated Nigeria’s readiness for deep global engagement in the pharmaceutical space.
The agency expressed profound gratitude to President Bola Ahmed Tinubu, the Minister of Health and Social Welfare, and various local and international partners for their consistent support. NAFDAC concluded its statement by reiterating its commitment to continue safeguarding the health of the nation, now armed with the “full strength of the ICH global community behind us,” fostering both innovation and quality manufacturing in the pharmaceutical industry.
