Clinical investigation of medicinal products for the management of Crohn's disease - Scientific guideline
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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
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Guideline on the development of new medicinal products for the treatment of Crohn’s Disease - Revision 2 (PDF/208.71 KB)
Adopted
First published: 23/07/2018
Last updated: 23/07/2018
Legal effective date: 01/01/2019
CPMP/EWP/2284/99 Rev. 2 -
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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) (PDF/683.15 KB)
First published: 23/07/2018
Last updated: 23/07/2018
EMA/CHMP/261409/2017 -
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Draft guideline on the development of new medicinal products for the treatment of Crohn’s Disease - Revision 2 (PDF/185.43 KB)
Draft: consultation closed
First published: 01/08/2016
Last updated: 01/08/2016
Consultation dates: 01/08/2016 to 31/01/2017
CPMP/EWP/2284/99 Rev. 2 -
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Draft concept paper on the revision of the guideline on the development of new medicinal products for the treatment of Crohn’s disease (PDF/89.81 KB)
Draft: consultation closed
First published: 01/10/2014
Last updated: 01/10/2014
Consultation dates: 01/10/2014 to 31/12/2014
EMA/CHMP/328077/2014 -
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Concept paper on the revision of the guideline on the development of new medicinal products for the treatment of Crohn’s disease (PDF/127.78 KB)
Draft: consultation closed
First published: 31/10/2012
Last updated: 14/11/2012
Consultation dates: 14/11/2012 to 15/02/2013
EMA/CHMP/396984/2012 -
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Guideline on the development of new medicinal products for the treatment of Crohn's disease - Revision 1 (PDF/60.82 KB)
Adopted
First published: 24/07/2008
Last updated: 24/07/2008
Legal effective date: 01/02/2009
CPMP/EWP/2284/99 Rev. 1 -
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Overview of comments received on draft guideline on the development of new medicinal products for the treatment of Crohn's disease (PDF/256.46 KB)
First published: 18/09/2008
Last updated: 18/09/2008
EMEA/492092/2008 -
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Draft guideline on the development of new medicinal products for the treatment of Crohn's disease (PDF/103.54 KB)
Draft: consultation closed
First published: 22/02/2007
Last updated: 22/02/2007
CPMP/EWP/2284/99 Rev. 1 -
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Concept paper on the revision of the CHMP points to consider on clinical investigation of medicinal products for the management of Crohn's disease (PDF/41.08 KB)
First published: 26/01/2006
Last updated: 26/01/2006
CHMP/EWP/18446/2006