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

Current version

PDF iconDraft guideline

Reference numberEMA/CHMP/187859/2017
Published06/04/2018
KeywordsAntibacterial agents, paediatric population, paediatric bacterial infections, extrapolation of efficacy, paediatric study designs, timing paediatric studies
DescriptionThis document proposes the development of an addendum to the Guideline on the evaluation of medicines indicated for treatment of bacterial infections, to provide specific guidance on paediatric clinical development programmes to support the authorisation of antibacterial agents for treating infectious diseases in children.

Document history

First version
Current version

PDF iconDraft guideline



PDF iconConcept paper

Published: 06/04/2018
Deadline for comments: 30 October 2018


Published: 20/04/2016

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