Evaluation of medicinal products for the treatment of irritable bowel syndrome - Scientific guideline

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)

Current effective version

Guideline on the evaluation of medicinal products for the treatment of irritable bowel syndrome - Revision 1

Adopted Reference Number: CPMP/EWP/785/97 Rev. 1 Summary:

This guideline intends to address the EU regulatory position in the main topics of clinical development of new medicinal products in the treatment of patients with Irritable Bowel Syndrome (IBS).

Document history

Guideline on the evaluation of medicinal products for the treatment of irritable bowel syndrome - Revision 1

Adopted Reference Number: CPMP/EWP/785/97 Rev. 1 Summary:

This guideline intends to address the EU regulatory position in the main topics of clinical development of new medicinal products in the treatment of patients with Irritable Bowel Syndrome (IBS).

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)

Reference Number: EMA/CHMP/266108/2014 Summary:

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)

Draft guideline on the evaluation of medicinal products for the treatment of irritable bowel syndrome - Revision 1

Draft: consultation closed Consultation dates: 19/07/2013 to 15/01/2014 Reference Number: CPMP/EWP/785/97 Rev. 1

Concept paper on the revision of the CHMP points to consider on the evaluation of medicinal products for the treatment of irritable bowel syndrome

Draft: consultation closed Consultation dates: 08/06/2012 to 31/08/2012 Reference Number: EMA/CHMP/172616/2012 Summary:

The proposed guideline will replace 'points to consider on the evaluation of medicinal products for the treatment of irritable bowel syndrome CPMP/EWP/785/97'. Irritable bowel syndrome (IBS) is a functional gastrointestinal disorder in which abdominal discomfort or pain is associated with changes in bowel habits, stool consistency and other features of disordered defecation.

Points to consider on the evaluation of medicinal products for the treatment of Irritable Bowel Syndrome

Adopted Reference Number: CPMP/EWP/785/97 Legal effective date: 01/09/2003