Evaluation of medicinal products for the treatment of irritable bowel syndrome - Scientific guideline
Table of contents
This 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.
Keywords: Irritable bowel syndrome, Rome criteria, patient reported outcome (PRO), health related quality of life (HrQoL)
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Guideline on the evaluation of medicinal products for the treatment of irritable bowel syndrome - Revision 1 (PDF/230.59 KB)
Adopted
First published: 25/09/2014
Last updated: 25/09/2014
CPMP/EWP/785/97 Rev. 1 -
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Overview of comments received on guideline on the evaluation of medicinal products for the treatment of irritable bowel syndrome (CPMP/EWP/785/97 Rev. 1) (PDF/213.71 KB)
First published: 25/09/2014
Last updated: 25/09/2014
EMA/CHMP/266108/2014 -
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Draft guideline on the evaluation of medicinal products for the treatment of irritable bowel syndrome - Revision 1 (PDF/200.82 KB)
Draft: consultation closed
First published: 19/07/2013
Last updated: 19/07/2013
Consultation dates: 19/07/2013 to 15/01/2014
CPMP/EWP/785/97 Rev. 1 -
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Concept paper on the revision of the CHMP points to consider on the evaluation of medicinal products for the treatment of irritable bowel syndrome (PDF/73.55 KB)
Draft: consultation closed
First published: 08/06/2012
Last updated: 08/06/2012
Consultation dates: 08/06/2012 to 31/08/2012
EMA/CHMP/172616/2012 -
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Points to consider on the evaluation of medicinal products for the treatment of Irritable Bowel Syndrome (PDF/175.02 KB)
Adopted
First published: 19/03/2003
Last updated: 19/03/2003
Legal effective date: 01/09/2003
CPMP/EWP/785/97