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

The development of clinical breakpoints for 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 advised 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:

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Guidance document on Reference and standardised susceptibility testing methods for new agents for the inclusion in EUCAST methods and interpretation (April 2024)

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The working order between the pharmaceutical industry, EUCAST and EMA (updated 2019)

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SOP 1.5 Setting breakpoints for new antimicrobial agents (9 May 2025)

Download SOP 1.5

SOP 9.4 Procedure for establishing zone diameter breakpoints and quality control criteria for new antimicrobial agents (10 July 2025)

Download SOP 9.4

SOP 10.2 MIC distributions and the setting of epidemiological cut-off (ECOFF) values (2 December 2021, reaffirmed 12 May 2025)

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SOP 11.1 Procedure for optimizing disk contents (potencies) for disk diffusion testing of antimicrobial agents using harmonized CLSI and EUCAST criteria (21 January 2025)

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SOP 12.1 Process for submitting disk content (potency) data for joint CLSI and EUCAST working group review and approval (11 March 2025)

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SOP 13.0 Procedure for confirming the acceptability of Mueller-Hinton agar sources for subsequent use in CLSI and/or EUCAST studies to establish disk diffusion quality control ranges (21 September 2023, re-affirmed 13 April 2025)

Download SOP 13.0

Guidance document on modification of antimicrobial susceptibility testing methods (August 2025)

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Template for creating a company rationale document (updated February, 2025)

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For previous version of documents visit EUCAST SOPs.

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