NAFDAC ICH Membership: Nigeria Joins World’s Top Drug Regulators
The National Agency for Food and Drug Administration and Control (NAFDAC) has made history by officially becoming a full member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), placing Nigeria among the world’s leading national drug regulatory authorities.
The announcement was made at the latest ICH Assembly in Singapore, confirming that NAFDAC’s elevation from observer status to full membership is now official. The milestone is a recognition of Nigeria’s compliance with internationally harmonised pharmaceutical standards and demonstrates the country’s capacity to regulate medicines at a global level.
Historic Achievement Through NAFDAC ICH Membership for Nigeria and Africa
Director-General Mojisola Adeyeye described the development as “historic for Nigeria and the African continent,” emphasizing that it reflects the dedication, expertise, and professionalism of Nigeria’s regulatory scientists.
“This achievement shows that NAFDAC can stand shoulder to shoulder with the best regulators in the world. It will ensure that Nigerians have access to safe, effective, and high-quality medicines,” Adeyeye said.
She added that the membership would strengthen regulatory oversight, improve compliance in the pharmaceutical industry, and accelerate access to innovative therapies in Nigeria.
Journey to Full ICH Status: NAFDAC ICH Membership Process
NAFDAC began its path to full ICH membership in 2022, initially gaining observer status. Over the past two years, the agency undertook extensive capacity-building initiatives, including:
Staff training on key ICH guidelines and technical standards.
Participation in multiple Expert Working Groups, contributing to global regulatory discussions.
Hosting international workshops, including sessions on bioequivalence (M13A) and quality management, bringing regulators and manufacturers from across Africa together.
Implementing internationally recognised processes for evaluating medicines and ensuring compliance with global standards.
The process required rigorous evaluation by ICH, and NAFDAC met all criteria, earning its place among only 25 national regulatory authorities worldwide recognised for global regulatory excellence.
Impact on Public Health and Pharmaceutical Sector
Analysts say NAFDAC’s new status will have significant effects on both public health and the pharmaceutical industry:
Public Health: Greater oversight means safer medicines, reduced circulation of substandard or counterfeit drugs, and increased access to effective treatments.
Pharmaceutical Industry: Local manufacturers can now align with global standards, attract foreign investment, and explore export opportunities.
Global Standing: Nigeria can now actively influence international pharmaceutical guidelines, contributing to policymaking and global health regulation.
This achievement comes alongside NAFDAC’s previous regulatory milestones, including retention of the WHO Maturity Level 3 (ML3) ranking for medicines and vaccine regulation, further cementing its reputation as a top African regulator.
NAFDAC says it will continue to:
Strengthen international collaboration to adopt emerging best practices.
Promote innovation in medicine regulation, improve access to high-quality drugs, and ensure that Nigerians benefit directly from enhanced regulatory oversight.
With full ICH membership, NAFDAC has set a new benchmark for African regulatory agencies, proving that Nigeria can compete globally in pharmaceutical regulation. The agency assured that this historic step will translate into tangible benefits for Nigerians, from safer medicines to better healthcare delivery nationwide.
