Development of new medicinal products for the treatment of ulcerative colitis - Scientific guideline

This 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.

Keywords: Drug evaluation, drug approval, ulcerative colitis

Current effective version

Guideline on the development of new medicinal products for the treatment of Ulcerative Colitis - Revision 1

AdoptedLegal effective date: 01/01/2019Reference Number: CHMP/EWP/18463/2006 Rev.1

Document history

Guideline on the development of new medicinal products for the treatment of Ulcerative Colitis - Revision 1

AdoptedLegal effective date: 01/01/2019Reference Number: CHMP/EWP/18463/2006 Rev.1

Overview of comments received on ''Draft guideline on the development of new medicinal products for the treatment of Ulcerative Colitis' (EMA/CHMP/EWP/18463/2006 Rev. 1)

Reference Number: EMA/CHMP/354664/2017

Draft guideline on the development of new medicinal products for the treatment of Ulcerative Colitis - Revision 1

Consultation dates: 01/08/2016 to 31/01/2017Draft: consultation closedReference Number: CHMP/EWP/18463/2006 Rev. 1Summary:

This is the 1st revision of the guideline on the development of new medicinal products for the treatment of Ulcerative Colitis.

The main aim of this 1st revision is to update the guidance on the design of studies in adult patients, especially on potential claims, primary and secondary endpoints and comparators. It is also intended to give further guidance with regards the possibility for extrapolation from adults, or the need to generate separate data in children and to give recommendations regarding the exploration of PK/PD in paediatric drug development.

Draft concept paper on the revision of the guideline on the development of new medicinal products for the treatment of ulcerative colitis

Consultation dates: 01/10/2014 to 31/12/2014Draft: consultation closedReference Number: EMA/CHMP/327812/2014Summary:

The scope of this planned revision to the guideline on the development of new medicinal products for the treatment of ulcerative colitis was extended to include adult as well as paediatric populations in October 2014. A previous version of this concept paper released for consultation in November 2012 only concerned paediatric populations.

Concept paper on the revision of the guideline on the development of medicinal products for the treatment of ulcerative colitis

Consultation dates: 14/11/2012 to 15/02/2013Draft: consultation closedReference Number: EMA/CHMP/204354/2012Summary:

The proposed guideline will replace the guideline on the development of medicinal products for the treatment of ulcerative colitis (CHMP/EWP/18463/2006).

Guideline on the development of new medicinal products for the treatment of ulcerative colitis

AdoptedLegal effective date: 01/08/2008Reference Number: CHMP/EWP/18463/2006

Overview of comments received on draft guideline on the development of new medicinal products for the treatment of ulcerative colitis

Legal effective date: 01/08/2008Reference Number: EMEA/468539/2007

Draft guideline on the development of new medicinal products for the treatment of ulcerative colitis

Draft: consultation closedReference Number: CHMP/EWP/18463/2006