Information for pharmaceutical companies intending to bring new antimicrobial drugs to EUCAST for breakpoints

The working order between pharmaceutical industry, EMA and EUCAST in preparation for obtaining breakpoints through EUCAST. 

• The working order between industry, EMA and EUCAST (updated 2019).
• Developing disk contents (potency) for new agents - see SOPs 11 - 13.
• Template for creating a company rationale document (pdf format) (updated February, 2025).
• The development of new agents requires agreement and acceptance of the data generated in support of decisions on clinical breakpoints, wild type MIC distributions, ECOFFs and routine susceptibility testing correlates. EUCAST and CLSI both favour the use of the unadulterated ISO recommended reference broth microdilution for this purpose, and only occasionally is there good reason to deviate from this. When this is considered necessary it is strongly adviced that this is with the agreement and full understanding of standards committees and agencies, such as CLSI, EUCAST, FDA and EMA. For this purpose EUCAST has published a guidance document on Reference and standardised susceptibility testing methods for new agents for the inclusion in EUCAST methods and interpretation (April 2024).