The National Agency for Food and Drug Administration and Control (NAFDAC) has secured a significant diplomatic and regulatory victory, achieving full membership of the prestigious International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
This “historic” transition from an Observer to a full member was announced at the ICH Assembly in Singapore, positioning Nigeria among an exclusive global group of just twenty-five national regulatory bodies committed to upholding the world’s highest scientific and technical standards for medicine development.
Professor Mojisola Adeyeye, the Director-General of NAFDAC, described the achievement as a watershed moment for the country’s health and economy.
“This accomplishment places Nigeria among global leaders committed to the highest standards of quality, safety, and efficacy of medicines,” Professor Adeyeye said in a statement. “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 was detailed by the Director-General, explaining that the process began with an application for Observer status in late 2022. Over the subsequent two years, NAFDAC staff embarked on an intensive capacity-building programme, which included rigorous training on multiple ICH guidelines and dedicated participation in Expert Working Groups.
The agency sealed its commitment in April 2025 by successfully hosting an international workshop on ICH M13A (Bioequivalence) in Lagos, bringing together local manufacturers and regional regulatory heads. Professor Adeyeye commended her staff, noting that their “rigorous scientific input and countless hours of document review helped show that Nigerian regulatory scientists can stand shoulder-to-shoulder with global experts.”
The Nigerian Ambassador to Singapore, H.E. Omayuli Francisca Kemi, welcomed the achievement, noting that NAFDAC was “bringing Nigeria into an exclusive circle of global regulatory excellence,” a move that boosts the country’s reputation on the world stage.
Beyond public health and safety, the full ICH membership is poised to deliver a major economic boost to Nigeria’s domestic pharmaceutical industry. Membership signifies that NAFDAC’s regulatory processes are harmonised with those used by key global markets in Europe, North America, and Asia.
This alignment drastically reduces the time and cost associated with obtaining approvals for products intended for export. Nigerian pharmaceutical firms will see their products gain immediate credibility and reduced scrutiny in foreign markets, potentially unlocking billions of Naira in export revenue and attracting significant foreign direct investment (FDI) into the sector.
A pharmaceutical industry analyst highlighted that this status provides a seal of quality assurance that transcends local borders. The analyst suggested that the membership is a “massive trade facilitator,” turning Nigeria’s local pharmaceutical production into a serious competitor in African and Middle Eastern markets, where global certification is highly valued.
NAFDAC further outlined that the new status will grant Nigerian companies improved product quality, better market competitiveness, and increased opportunities for joint ventures with major international pharmaceutical companies. Furthermore, the agency itself can now actively shape and implement global harmonised technical guidelines.
Professor Adeyeye thanked the Federal Government for its support, noting that the achievement ensures sustainability of reforms under the current administration. “This is a proud moment for NAFDAC, for Nigeria… and for Africa,” she concluded. “We will continue to safeguard public health now reinforced with the full strength and collaboration of the ICH global community.”
