Concept paper on preparation of a revised guideline on the evaluation of medicinal products indicated for treatment of bacterial infections

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Download document Concept paper on preparation of a revised guideline on the evaluation of medicinal products indicated for treatment of bacterial infections
Reference number EMA/CHMP/75653/2018
Status draft: consultation open
First published 2018-06-13
Last updated 2018-06-13
Consultation start date 2018-06-13
Consultation end date 2018-09-13
Email address for submissions idwpsecretariat@ema.europa.eu

Summary

This concept paper proposes the development of a single guideline on the clinical evaluation of medicinal products indicated for treatment of bacterial infections. The development of this single guideline is intended to merge, revise and add to the guidance that is currently included in two separate documents as follows: guideline on the evaluation of medicinal products indicated for treatment of bacterial infections (CPMP/EWP/558/95 Rev. 2), adopted in 2011 and in force since 2012 and the addendum to the guideline on the evaluation of medicinal products indicated for treatment of bacterial infections (EMA/CHMP/351889/2013), adopted in 2013 and in force since 2014.