Evaluation of medicinal products indicated for treatment of bacterial infections

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Current effective version

Revision 2 - Adopted guideline

Currently under revision - see below

Reference numberCPMP/EWP/558/95 Rev. 2
Effective from15/01/20012
KeywordsNon-inferiority studies, superiority studies, susceptibility testing, pharmacokinetic/pharmacodynamic (PK/PD) relationship, bacteraemia, febrile neutropenia, eradication of carriage, drug-resistant organisms; paediatric investigation plan (PIP)
DescriptionThis document considers the microbiological and clinical data required to support indications, dose regimens and durations of therapy for antibacterial agents. It also addresses the layout and wording of some sections of the summary of product characteristics. Read together with the addendum to specifically address the clinical development of new agents to treat disease due to Mycobacterium tuberculosis and the addendum to address indication-specific clinical data requirements.

Document history

Revision 3

In progress

Concept paper

Published: 13/06/2018

Deadline for comments: 13/09/2018

Revision 2

Current version

Adopted guideline


Draft guideline


Concept paper

In operation: 15/01/2012-present


Published: 25/03/2010


Published: 19/02/2009

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