Evaluation of medicinal products indicated for treatment of bacterial infections - Scientific guideline

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)

Minimum inhibitory concentration (MIC) breakpoints

Minimum inhibitory concentration (MIC) breakpoints refer to specific concentrations of an 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: 

This document presents MIC information in a tabular format. It contains separate tabs for each active substance, in alphabetical order.

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 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.

PI documents will continue to provide guidance on the approved dosage of antibacterials.

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.

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