Clinical investigation of medicinal products for the management of Crohn's disease

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Current effective version

Revision 1 - Adopted guideline

Currently under revision - see below

Reference numberCPMP/EWP/2284/99 Rev. 1
Effective from01/02/2009
KeywordsCrohn’s disease
DescriptionThis document provides guidance on the clinical development of new medicinal products in the treatment of Crohn’s disease. It applies to the confirmatory studies involving the drug treatment of this disease. It does not address generic drug development.

Document history

Revision 2

In progess

Draft guideline


Concept paper

Concept paper

Published: 01/08/2016
Deadline for comments: 31/01/2017


Published: 01/10/2014

Published: 14/11/2012

Revision 1 

Current version

Adopted guideline

Overview of comments

Draft guideline

Concept paper

In operation: 01/02/2009–present

Published: 18/09/2008

Published: 22/02/2007

Published: 26/01/2006

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