WHO List of International Comparator Products

Overview

The list of international comparator products provides tabulated information about pharmaceutical products on the World Health Organization (WHO) Model List of Essential Medicines (EML), specific finished pharmaceutical products that can be selected as comparators (column headed “International comparator product”) and the markets where the product’s quality, safety and efficacy is considered as best documented (column headed “Market”). This list is for identifying comparator products for equivalence assessment of interchangeable multisource (generic) products. Comparator products recommended by the WHO Prequalification Team – Medicines (PQTm) are included in the list of international comparator products (column headed “PQ comparator product”). The list is compiled based on data publicly available and information provided by medicines regulatory authorities and manufacturers. 

WHO Team
Health Product Policy and Standards (HPS), Norms and Standards for Pharmaceuticals (NSP), Technical Standards and Specifications (TSS)
Reference numbers
WHO Reference Number: WHO/MHP/HPS/TSS/NSP/2024.2