International Nonproprietary Names (INNs)

Learn how International Nonproprietary Names (INNs) are created, requested, and approved by the World Health Organization (WHO). This concise regulatory walkthrough covers the full INN process — from dossier preparation and submission requirements to fee structure, timing considerations, and final approval steps. Perfect for Regulatory Affairs professionals, clinical development teams, and anyone working with drug naming, labeling, or global submissions. What you’ll learn: What INNs are and why they matter How to prepare an INN request WHO submission requirements INN fee and timing considerations How WHO evaluates and approves INNs Practical tips for sponsors and regulatory teams Resources mentioned: WHO/OMS Extranet Systems WHO INN Online Application WHO Health Products Policy & Standards WHO 83rd INN Consultation If you found this helpful, subscribe for more Regulatory Affairs 101 content.