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

This 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.

Keywords: Non-inferiority study designs, superiority study designs, rare and multidrug-resistant organisms, pathogen-specific indications

Current effective version

Addendum to the guideline on the evaluation of medicinal products indicated for treatment of bacterial infections

Adopted Reference Number: EMA/CHMP/351889/2013 Summary:

During the revision of the Guideline on evaluation of medicinal products indicated for treatment of bacterial infections (CPMP/EWP/558/95 Rev 2) consideration was given to the need to provide recommendations for the design of clinical studies intended to support the approval of specific indications for use.

Document history

Draft addendum to the note for guidance on evaluation of medicinal products indicated for treatment of bacterial infections (CPMP/EWP/558/95 rev 2) to address indication-specific clinical data

Draft: consultation closed Consultation dates: 04/07/2012 to 31/01/2013 Reference Number: EMA/CHMP/776609/2011 Summary:

This is an addendum to the guideline on evaluation of medicinal products indicated for treatment of bacterial infections (CPMP/EWP/558/95 rev 2). It provides recommendations on the design of clinical studies intended to support the approval of specific indications, with detailed advice on several issues including patient selection criteria, primary endpoints, indications for which superiority or non-inferiority study designs would be expected and suggestions for non-inferiority margins. The need for this addendum was identified during the revision of the guideline.

Concept paper on an addendum to the note for guidance on evaluation of medicinal products indicated for treatment of bacterial infections (CPMP/EWP/558/95 rev 2) to address indication-specific clinical data requirements

Draft: consultation closed Consultation dates: 22/09/2011 to 31/12/2011 Reference Number: EMA/CHMP/EWP/736904/2011 Summary:

This Concept Paper proposes the development of an addendum to the Note for Guidance on Evaluation

of New Anti-bacterial Medicinal Products (CPMP/EWP/558/95 Rev 2).