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

Current effective version

Guideline on clinical investigation of medicinal products for the treatment of multiple sclerosis - Revision 2

Adopted Reference Number: EMA/CHMP/771815/2011 Rev. 2 Legal effective date: 01/10/2015

Document history - Revision 2 (current version)

Guideline on clinical investigation of medicinal products for the treatment of multiple sclerosis - Revision 2

Adopted Reference Number: EMA/CHMP/771815/2011 Rev. 2 Legal effective date: 01/10/2015

Draft guideline on clinical investigation of medicinal products for the treatment of multiple sclerosis - Revision 2

Draft: consultation closed Consultation dates: 09/10/2012 to 09/04/2013 Reference Number: EMA/CHMP/771815/2011, Rev 2 Summary:

This guideline replaces the guideline on clinical investigation of medicinal products for the treatment of multiple sclerosis (CPMP/EWP/561/98, revision 1).

Concept paper on the need for revision of guideline on clinical investigation of medicinal products for the treatment of multiple sclerosis

Draft: consultation closed Consultation dates: 23/06/2011 to 30/09/2011 Reference Number: EMA/CHMP/CNSWP/257565/2011 Summary:

The increase in applications of new products in the treatment of multiple sclerosis and numerous scientific advices given concerning multiple sclerosis indicates that the treatment of multiple sclerosis is a moving and changing field. In addition the current treatment options have changed the multiple sclerosis population.

Document history - Revision 1

Guideline on clinical investigation of medicinal products for the treatment of multiple sclerosis - Revision 1

Adopted Reference Number: CPMP/EWP/561/98 Rev. 1 Legal effective date: 01/06/2007

Overview of comments received on draft guideline on multiple sclerosis

Reference Number: CHMP/EWP/438043/2006

Draft guideline on clinical investigation of medicinal products for the treatment of multiple sclerosis - Revision 1

Draft: consultation closed Reference Number: EMEA/CHMP/EWP/561/98 Rev 1