116
By Daniel Adaji
The National Agency for Food and Drug Administration and Control (NAFDAC) has been admitted as a full member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
This follows it’s transition from its former Observer status.
In a statement on Friday, the Agency described the development as a “historic milestone in Nigeria’s regulatory space.”
The announcement was made by the ICH Assembly during its in-person meeting held on 18–19 November 2025 in Singapore, and later confirmed through an official press release issued on 26 November 2025. With this move, Nigeria becomes the 24th member within a select group of 25 national regulatory authorities worldwide implementing globally harmonised, science-based pharmaceutical standards.
According to NAFDAC, the membership elevates the country into the ranks of global leaders committed to the highest standards of quality, safety, and efficacy of medicines.
The Agency noted that “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.”
The journey to full membership began in late 2022 after the Director General was advised to apply for Observership. Upon application and approval, NAFDAC attended the 2023 ICH meeting in Vancouver, Canada, where it delivered a formal presentation as part of the evaluation process. The Agency was then granted Observership and handed a set of requirements it needed to meet.
Over the next two years, the institution undertook extensive capacity-building, including training on several ICH guidelines and active participation in Expert Working Groups. The Agency said these were critical steps in a “methodical and structured approach” that made the achievement possible. It also acknowledged support from Northeastern University, Boston, USA, and the Bill & Melinda Gates Foundation for various training programmes.
NAFDAC fulfilled the final requirements in April 2025 following an international workshop on ICH M13A (Bioequivalence), where it brought together manufacturers in Lagos and held virtual engagements with heads of regional regulatory authorities.
This membership shift carries major implications for Nigeria. The Agency noted that full participation empowers it to shape and implement harmonised technical guidelines that align with global best practices, ultimately enabling better regulatory decisions. It said patients will gain from faster access to innovative therapies as international confidence in Nigeria’s regulatory systems grows.
The Agency added that the membership “strengthens NAFDAC’s technical workforce and institutional capacity,” improves the competitiveness of local manufacturers, enhances opportunities for foreign investment, and reinforces Nigeria’s position as a strategic partner within Africa, especially in supporting the African Medicines Agency’s vision.
The milestone also reflects the sustained leadership of the Director General, Prof. Mojisola Adeyeye, and the work of NAFDAC’s regulatory scientists. The Agency said it “proudly acknowledges the dedicated NAFDAC staff who have served and continue to serve as members of the ICH Expert Working Groups,” adding that their contributions show that Nigerian experts can “stand shoulder-to-shoulder with global experts, influencing standards that protect billions of people.”
It also recognised the role of staff who facilitated international trainings and commended the Federal Government for extending the Director General’s tenure under the Renewed Hope Agenda to ensure continuity of reforms.
Looking ahead, the Agency pledged its commitment to fully implementing ICH guidelines, strengthening Nigeria’s regulatory ecosystem, supporting pharmaceutical innovation, and upholding transparency, integrity, and science-based decision-making. It restated its mission of “Safeguarding the Health of the Nation.”
Describing the achievement as “a proud moment for NAFDAC, for Nigeria under the Renewed Hope Agenda of the President, and for Africa,” the Agency expressed gratitude to President Bola Ahmed Tinubu, the Minister of Health and Social Welfare, international partners, and Nigerians for their support.
NAFDAC said it will continue to safeguard public health, now with the added strength and collaboration of the ICH global community.