Development of new medicinal products for the treatment of ulcerative colitis

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Current effective version

Adopted guideline

Currently under revision - see below

Reference numberCHMP/EWP/18463/06
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

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

First version 

Current version

Adopted guideline


Overview of comments


Draft guideline

In operation: 01/08/2008–present


Published: 21/02/2008


Published: 16/11/2006

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