Development of new medicinal products for the treatment of ulcerative colitis

Current effective version

PDF iconAdopted guideline

Reference numberCHMP/EWP/18463/06
Published24/01/2008
Effective from01/08/2008
KeywordsDrug evaluation, drug approval, ulcerative colitis
DescriptionThis document provides guidance for the evaluation of new medicinal products in the treatment of ulcerative colitis. It clarifies the requirements for clinical documentation needed to support a marketing authorisation, the selection of patients, the recommended methods to assess efficacy, the strategy and design of clinical trials, safety aspects and overall strategy of development.


Document history

Revision 1

PDF iconAdopted guideline



PDF iconOverview of comments


PDF iconDraft guideline

PDF iconConcept paper

Concept paper

Published: 23/07/2018
Effective from: 01/01/2019

Published: 23/07/2019

Published: 01/08/2016

Published: 01/10/2014

Published: 14/11/2012

First version

Current version

PDF iconAdopted guideline

PDF iconOverview of comments

PDF iconDraft guideline

In operation: 01/08/2008–present

Published: 21/02/2008

Published: 16/11/2006


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