Dare Babalola
The National Agency for Food and Drug Administration and Control (NAFDAC) has announced a significant milestone in Nigeria’s regulatory space: its transition from an Observer Status to Full Membership of the International Council for Harmonisation (ICH).
“This achievement places Nigeria among global leaders committed to the highest standards of quality, safety, and efficacy of medicines,” said NAFDAC Director General, Prof. Mojisola Adeyeye, in a statement on Friday.
The ICH is a select body comprising leading regulatory authorities and the pharmaceutical industry, dedicated to advancing scientific and technical principles of pharmaceutical development.
Full membership empowers NAFDAC to shape and implement harmonised technical guidelines, leading to better regulatory decisions and improved public health outcomes.
She added, “Full membership empowers NAFDAC to actively shape and implement harmonised technical guidelines that match international best practices, leading to better regulatory decisions and improved public health outcomes.”
This development is expected to benefit Nigerians in several ways, including improved access to high-quality medicines, enhanced capacity and technical expertise, and increased confidence in Nigerian pharmaceutical products.
NAFDAC’s journey to full membership began in 2022, with the Agency undertaking capacity-building activities, training on ICH guidelines, and active participation in Expert Working Groups.
“NAFDAC’s journey toward full ICH membership commenced in the last quarter of 2022, when the Director General was advised to apply for Observership status,” the statement added.
Prof. Adeyeye expressed gratitude to President Bola Ahmed Tinubu, the Honourable Minister of Health and Social Welfare, local and international partners, and the Nigerian people for their support.
“This achievement did not happen overnight. It is the result of years of sustained commitment, leadership under the Director General, Prof Moji Adeyeye, and technical excellence across the Agency.”
NAFDAC remains committed to implementing ICH guidelines, strengthening Nigeria’s regulatory ecosystem, and supporting local pharmaceutical innovation and manufacturing.
The Agency’s full membership in ICH marks a significant step forward in ensuring Nigerians have access to safe, high-quality, and effective medicines.
