Evaluation of medicinal products for the treatment of irritable bowel syndrome

Current effective version

PDF iconRevision 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

PDF iconAdopted guideline


PDF iconOverview of comments


PDF iconDraft guideline


Concept paper

In operation: 01/04/2015–present


Published: 25/09/2014


Published: 19/07/2013


Published: 08/06/2012

First version PDF iconAdopted guideline In operation: 01/09/2003–01/04/2015


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