Follow Us on Google
By Doris Obinna
Nigeria has surged into the top tier of global drug regulation, with the National Agency for Food and Drug Administration and Control (NAFDAC) securing full membership of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), a milestone that places the country among an elite group of 25 national regulatory authorities worldwide.
The announcement, made at the ICH Assembly in Singapore on November 18 and 19, 2025 and published officially on November 26, marks the end of a fast-paced, methodical ascent that began barely three years ago. It is a breakthrough with profound implications for the safety, quality and global credibility of medicines available to Nigerians.
NAFDAC in a statement disclosing this stated that the agency’s rise from observer to full member is the culmination of a deliberate strategy launched in late 2022, when the agency first applied for observership and was invited to present at the 2023 ICH meeting in Vancouver. “What followed was an intensive period of capacity building, internal reforms and scientific engagement.
NAFDAC officers underwent extensive training on multiple ICH guidelines, deepened their work in Expert Working Groups, and demonstrated practical implementation of harmonised regulatory standards.
“The final requirement was met in April 2025 after the agency convened a high-level international workshop on the ICH M13A guideline on bioequivalence, bringing together manufacturers, regional regulators and global experts. Support from Northeastern University in Boston and the Bill & Melinda Gates Foundation further strengthened the initiative and prepared the agency for its evaluation.”
For Nigeria, the achievement is far more than symbolic. Full ICH membership equips NAFDAC with the authority to shape global technical guidelines and aligns the country with standards used by the world’s most advanced regulatory systems. It is expected to accelerate patients’ access to safe, high-quality, innovative medicines and enhance confidence in Nigerian-made pharmaceutical products, both locally and internationally.
Industry analysts say the move could unlock new investment opportunities, enabling local manufacturers to compete globally and collaborate more effectively with multinational drug companies. It also positions Nigeria as a strategic regulatory player in Africa, reinforcing continental efforts toward a harmonised framework under the African Medicines Agency.
Other News
The victory is also being celebrated as a triumph of leadership and institutional continuity. Staff members who contributed to years of technical submissions, scientific reviews and international deliberations have been credited with proving Nigeria’s regulatory competence on the world stage.
The Director General, Prof. Moji Adeyeye, whose tenure was extended to consolidate the gains of her first term under the Renewed Hope Agenda was commended for steering the agency through a rigorous and highly competitive process.
Nigeria’s Ambassador to Singapore, H.E. Omayuli Francisca Kemi, received the news alongside the visiting NAFDAC delegation and described the development as a turning point for Nigeria’s global regulatory standing.
In the statement following the announcement, the agency reaffirmed its commitment to fully implementing ICH guidelines, supporting local innovation, enhancing transparency and strengthening Nigeria’s regulatory environment. “Safeguarding the health of the nation,” the agency said, “remains our mandate now reinforced with the full strength of the ICH global community.”
