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

Document history

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

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)

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

Draft concept paper on the revision of the guideline on the development of new medicinal products for the treatment of Crohn’s disease

Concept paper on the revision of the guideline on the development of new medicinal products for the treatment of Crohn’s disease

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

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

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

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

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