Evaluation of medicinal products for the treatment of irritable bowel syndrome

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Current effective version

Revision 1 - Adopted guideline

Reference numberCHMP/BWP/457920/2012 Rev. 1
Published25/09/2014
Effective from01/04/2015
KeywordsIrritable bowel syndrome, Rome criteria, patient reported outcome (PRO), health related quality of life (HrQoL)
DescriptionThis document addresses the European Union regulatory position in the main topics of clinical development of new medicinal products in the treatment of irritable bowel syndrome.


Document history

Revision 1 

Current version

Adopted guideline


Overview of comments


Draft guideline


Concept paper

In operation: 01/04/2015–present


Published: 25/09/2014


Published: 19/07/2013


Published: 08/06/2012

First versionAdopted guidelineIn operation: 01/09/2003–01/04/2015


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