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

This 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

Keywords: Crohn's disease

Current effective version

Guideline on the development of new medicinal products for the treatment of Crohn’s Disease - Revision 2

Adopted Reference Number: CPMP/EWP/2284/99 Rev. 2 Legal effective date: 01/01/2019

Document history

Guideline on the development of new medicinal products for the treatment of Crohn’s Disease - Revision 2

Adopted Reference Number: CPMP/EWP/2284/99 Rev. 2 Legal effective date: 01/01/2019

Overview of comments received on 'draft guideline on the development of new medicinal products for the treatment of Crohn’s Disease' (EMA/CPMP/EWP/2284/99 Rev. 2)

Reference Number: EMA/CHMP/261409/2017

Draft guideline on the development of new medicinal products for the treatment of Crohn’s Disease - Revision 2

Draft: consultation closed Consultation dates: 01/08/2016 to 31/01/2017 Reference Number: CPMP/EWP/2284/99 Rev. 2 Summary:

This is the 2nd revision of the guideline on the development of new medicinal products for the treatment of Crohn’s Disease.

The main aim of this 2nd revision was 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 Crohn’s disease

Draft: consultation closed Consultation dates: 01/10/2014 to 31/12/2014 Reference Number: EMA/CHMP/328077/2014 Summary:

The scope of this planned revision to the guideline on the development of new medicinal products for the treatment of Crohn’s disease 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 new medicinal products for the treatment of Crohn’s disease

Draft: consultation closed Consultation dates: 14/11/2012 to 15/02/2013 Reference Number: EMA/CHMP/396984/2012 Summary:

The proposed guideline will replace the guideline on the development of new medicinal products for the treatment of Crohn’s disease (CPMP/EWP/2284/99 Rev. 1).

Guideline on the development of new medicinal products for the treatment of Crohn's disease - Revision 1

Adopted Reference Number: CPMP/EWP/2284/99 Rev. 1 Legal effective date: 01/02/2009

Overview of comments received on draft guideline on the development of new medicinal products for the treatment of Crohn's disease

Reference Number: EMEA/492092/2008

Draft guideline on the development of new medicinal products for the treatment of Crohn's disease

Draft: consultation closed Reference Number: CPMP/EWP/2284/99 Rev. 1

Concept paper on the revision of the CHMP points to consider on clinical investigation of medicinal products for the management of Crohn's disease

Reference Number: CHMP/EWP/18446/2006