Nigeria's NAFDAC achieves a major milestone in global drug regulation!
In a significant development, the National Agency for Food and Drug Administration and Control (NAFDAC) has been granted full membership in the prestigious International Council for Harmonisation (ICH). This elite group comprises leading drug regulatory bodies and pharmaceutical industry leaders dedicated to elevating medicine development through scientific and technical excellence.
But here's where it gets exciting: NAFDAC's Director-General, Prof. Mojisola Adeyeye, announced that this achievement elevates Nigeria's status from an Observer to a full member, marking a historic transition. This move places Nigeria among the global elite committed to the highest standards of medicine quality, safety, and efficacy.
Prof. Adeyeye explained, "For Nigerian citizens, this means improved access to top-tier medical products. For our local pharmaceutical manufacturers, it opens doors to enhanced competitiveness and greater trust in Nigerian-made products both domestically and internationally."
And the journey began in 2022: NAFDAC's path to this achievement started when Prof. Adeyeye was advised to apply for Observer status. After a successful presentation at the 2023 ICH meeting in Vancouver, they were granted Observership and given a rigorous set of membership requirements to fulfill.
Over the next two years, NAFDAC engaged in intensive capacity-building, including training on various ICH guidelines and active participation in Expert Working Groups. This methodical approach, supported by Northeastern University, Boston, and the Bill & Melinda Gates Foundation, proved instrumental in achieving full membership.
NAFDAC met all the necessary criteria in April 2025, following a successful international workshop on bioequivalence in Lagos, which brought together local manufacturers and regional regulatory leaders. With this membership, Nigeria joins a select group of only 25 national regulatory authorities worldwide dedicated to implementing harmonized, science-based standards through the ICH framework.
The Nigerian Ambassador to Singapore, H.E. Omayuli Francisca Kemi, praised NAFDAC for bringing Nigeria into this exclusive circle of global regulatory excellence. The agency highlighted several benefits, including the ability to actively contribute to and implement harmonized technical guidelines aligned with international best practices.
"This will lead to faster patient access to cutting-edge, life-saving therapies as global confidence in Nigeria's regulatory processes increases," said Prof. Adeyeye. She added that membership provides access to advanced scientific knowledge, training, and collaboration, enhancing NAFDAC's technical capabilities. Nigerian pharmaceutical companies are anticipated to benefit from improved product quality, enhanced market competitiveness, and expanded foreign partnership opportunities.
A controversial aspect? Prof. Adeyeye's extended tenure by the Federal Government has been a subject of discussion. She acknowledged this decision, stating that it ensured the sustainability of achievements under the Renewed Hope Agenda. NAFDAC remains dedicated to implementing ICH guidelines, fortifying Nigeria's regulatory environment, fostering pharmaceutical innovation, and upholding transparency and scientific integrity.
Prof. Adeyeye expressed gratitude to President Bola Tinubu, the Minister of Health and Social Welfare, and various local and international partners for their support. She concluded, "This is a moment of pride for NAFDAC, Nigeria, and Africa. We will continue to protect public health, now bolstered by the full support and collaboration of the global ICH community."
