This guideline merges, revises and adds to the guidance previously included in the Guideline on the evaluation of medicinal products indicated for treatment of bacterial infections (CPMP/EWP/558/95 Rev 2) and the Addendum to the guideline on the evaluation of medicinal products indicated for treatment of bacterial infections (EMA/CHMP/351889/2013).

Keywords: Non-inferiority studies, superiority studies, susceptibility testing, pharmacokinetic / pharmacodynamic (PK/PD) relationship, bacteraemia, febrile neutropenia, eradication of carriage, drug-resistant organisms; paediatric investigation plan (PIP)

Current version

Guideline on the evaluation of medicinal products indicated for treatment of bacterial infections - Revision 3

English (EN) (507.08 KB - PDF)View

Minimum inhibitory concentration (MIC) breakpoints

Minimum inhibitory concentration (MIC) breakpoints refer to specific concentrations of an antibacterial or antifungal active substance expected to have an effect on a clinical infection produced by a given pathogen.

They indicate the probability of treatment success (susceptibility breakpoint) or failure (resistance breakpoint) when administered at an approved dosage and indication.

They are also known as susceptibility testing interpretative criteria (STIC).

These breakpoints can inform physicians of patients with a particularly complex infection, supporting them to identify an appropriate treatment course. 

From 1 December 2022, MIC information is centralised and made available in the document below: 

Minimum inhibitory concentration (MIC) breakpoints

English (EN) (345.94 KB - XLSX)View

This document presents MIC information in a tabular format. It contains separate tabs for each active substance, in alphabetical order. Antibacterial agents are listed first, followed by antifungal agents, in alphabetical order respectively.

It uses the following abbreviations:

  • "S" for susceptibility breakpoints;
  • "R" for resistance breakpoints; 
  • "IE" for where there is insufficient evidence that a bacteria or group of bacteria, or fungi or group of fungi, is a good target for therapy with a given active substance;
  • "IP" for breakpoints are under preparation.  

EMA is relocating this data from the product information (PI) of authorised products in order to ensure that the breakpoints for both centrally and nationally authorised products are kept up to date.

The document below contains the text for the summary of product characteristics referring to the MIC breakpoint document. The text is available in all EU languages.

If a footnote refers to additional information (flow charts, tables, other notes etc) not found in this document, please refer to the source documents on the EUCAST website.

Heading and text to be inserted in Section 5.1 of the SmPC

English (EN) (112.4 KB - DOCX)View

PI documents will continue to provide guidance on the approved dosage of antibacterial and antifungal medicinal products.

This data relocation followed the adoption of revision 3 of the guideline on the evaluation of medicinal products indicated for treatment of bacterial infections.

For more information on this guideline, see Current version.

Document history

Draft guideline on the evaluation of medicinal products indicated for treatment of bacterial infections - Revision 3

English (EN) (467.27 KB - PDF)View

Concept paper on preparation of a revised guideline on the evaluation of medicinal products indicated for treatment of bacterial infections - Revision 3

English (EN) (97.27 KB - PDF)View

Guideline on the evaluation of medicinal products indicated for treatment of bacterial infections - Revision 2

English (EN) (240.39 KB - PDF)View

Draft guideline on the evaluation of medicinal products indicated for treatment of bacterial infections - Revision 2

English (EN) (242.38 KB - PDF)View

Concept paper on the need for revision of the note for guidance on evaluation of medicinal products indicated for treatment of bacterial infections (CPMP/EWP/558/95 REV 1) - Revision 2

English (EN) (61.12 KB - PDF)View

How useful do you find this page?