NAFDAC joins elite group, achieves global drug regulator membership status

NAFDAC DG, Prof. Mojisola Adeyeye

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The National Agency for Food and Drug Administration and Control has secured full membership of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.

According to a statement signed by the Director-General of NAFDAC, Prof. Mojisola Adeyeye, on Friday, the announcement was made at the ICH Assembly held between November 18 and 19, 2025, in Singapore, and later published on the organisation’s website on November 26, 2025.

Describing the development as “historic,” NAFDAC said the achievement marked Nigeria’s transition from an Observer to a full member of the prestigious global body, which comprises leading drug regulatory authorities and pharmaceutical industry players committed to advancing scientific and technical principles in medicine development.

In the statement, Adeyeye, said the accomplishment “places Nigeria among global leaders committed to the highest standards of quality, safety, and efficacy of medicines.

“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.”

Adeyeye noted that the agency’s journey began in late 2022 when she was advised to apply for Observer status.

“Following our presentation at the 2023 ICH meeting in Vancouver, we were granted Observership and provided with rigorous membership requirements,” she said.

She explained that over the next two years, NAFDAC embarked on intensive capacity-building efforts, including training on multiple ICH guidelines and active participation in Expert Working Groups.

“The methodical and structured approach we adopted was central to this achievement,” she added, acknowledging the support received from Northeastern University, Boston, and the Bill & Melinda Gates Foundation for training programmes.

NAFDAC said it fulfilled all necessary membership criteria in April 2025 after successfully hosting an international workshop on ICH M13A (Bioequivalence) in Lagos, which brought together local manufacturers and regional regulatory heads.

With the admission, Nigeria becomes the 24th among only 25 national regulatory authorities globally committed to implementing harmonised, science-based standards through the ICH framework.

The Nigerian Ambassador to Singapore, H.E. Omayuli Francisca Kemi, who welcomed the NAFDAC team, commended the agency for “bringing Nigeria into an exclusive circle of global regulatory excellence.”

NAFDAC outlined several benefits of the full membership, including “the agency can now actively shape and implement harmonised technical guidelines that match international best practices.

“Patients will have faster access to innovative, life-saving therapies as global confidence in Nigeria’s regulatory processes grows. Membership offers access to advanced scientific knowledge, training, and collaboration, strengthening NAFDAC’s technical workforce.

“Nigerian pharmaceutical companies are expected to enjoy improved product quality, better market competitiveness, increased foreign partnership opportunities and stronger global partnerships. Nigeria’s new status strengthens its role in regional regulatory integration and supports the African Medicines Agency initiative.”

Adeyeye praised the agency’s staff, especially those serving in ICH Expert Working Groups.

“Their rigorous scientific input and countless hours of document review helped show that Nigerian regulatory scientists can stand shoulder-to-shoulder with global experts,” she said.

She also acknowledged the Federal Government for extending her tenure, noting that it ensured “sustainability of achievements under the Renewed Hope Agenda.”

NAFDAC said it remained committed to full implementation of ICH guidelines, strengthening Nigeria’s regulatory ecosystem, supporting pharmaceutical innovation, and maintaining transparency and scientific integrity.

“This is a proud moment for NAFDAC, for Nigeria under the Renewed Hope Agenda of the President, and for Africa. We will continue to safeguard public health—now reinforced with the full strength and collaboration of the ICH global community,” said Adeyeye.

The agency expressed gratitude to President Bola Tinubu, the Minister of Health and Social Welfare, and local and international partners for their support.

The PUNCH Senior Correspondent, Grace, has over 17 years experience covering education, arts, business and health sectors. She’s a graduate of Sociology

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