Clinical investigation of medicinal products for the treatment of multiple sclerosis - Scientific guideline
This document provides guidance on the evaluation of medicinal products for the treatment of multiple sclerosis. It primarily focuses on treatments aimed to modify disease progression. In addition it concerns the treatment of relapses, repair and restoration of functioning and symptomatic improvement.
Keywords: Multiple sclerosis, neurological disease
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Guideline on clinical investigation of medicinal products for the treatment of multiple sclerosis - Revision 2 (PDF/240.99 KB)
Adopted
First published: 31/03/2015
Last updated: 31/03/2015
Legal effective date: 01/10/2015
EMA/CHMP/771815/2011 Rev. 2 -
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Draft guideline on clinical investigation of medicinal products for the treatment of multiple sclerosis - Revision 2 (PDF/223.86 KB)
Draft: consultation closed
First published: 09/10/2012
Last updated: 09/10/2012
Consultation dates: 09/10/2012 to 09/04/2013
EMA/CHMP/771815/2011, Rev 2 -
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Concept paper on the need for revision of guideline on clinical investigation of medicinal products for the treatment of multiple sclerosis (PDF/134.64 KB)
Draft: consultation closed
First published: 08/07/2011
Last updated: 08/07/2011
Consultation dates: 23/06/2011 to 30/09/2011
EMA/CHMP/CNSWP/257565/2011
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Guideline on clinical investigation of medicinal products for the treatment of multiple sclerosis - Revision 1 (PDF/205.8 KB)
Adopted
First published: 16/11/2006
Last updated: 16/11/2006
Legal effective date: 01/06/2007
CPMP/EWP/561/98 Rev. 1 -
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Overview of comments received on draft guideline on multiple sclerosis (PDF/57.4 KB)
First published: 16/11/2006
Last updated: 16/11/2006
CHMP/EWP/438043/2006 -
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Draft guideline on clinical investigation of medicinal products for the treatment of multiple sclerosis - Revision 1 (PDF/123.26 KB)
Draft: consultation closed
First published: 15/09/2005
Last updated: 15/09/2005
EMEA/CHMP/EWP/561/98 Rev 1