Addendum to the note for guidance on evaluation of medicinal products indicated fortreatment of bacterial infections to address indication-specific clinical data requirements

Current effective version

PDF iconAdopted guideline

Reference numberEMA/CHMP/351889/2013
Published04/07/2012
Effective from01/05/2014
KeywordsNon-inferiority study designs, superiority study designs, rare and multidrug-resistant organisms, pathogen-specific indications
DescriptionThis document is an addendum to the guideline on the evaluation of medicinal products indicated for treatment of bacterial infections. It provides additional guidance on studies and clinical development programmes intended to support specific indications for use.


Document history

First version

Current version

PDF iconAdopted guideline

PDF iconDraft guideline

PDF iconConcept paper

In operation: 01/05/2014–present

Published: 04/07/2012

Published: 06/10/2011

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