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
English (EN) (240.99 KB - PDF)
Document history - Revision 2 (current version)
Guideline on clinical investigation of medicinal products for the treatment of multiple sclerosis - Revision 2
English (EN) (240.99 KB - PDF)
Draft guideline on clinical investigation of medicinal products for the treatment of multiple sclerosis - Revision 2
This guideline replaces the guideline on clinical investigation of medicinal products for the treatment of multiple sclerosis (CPMP/EWP/561/98, revision 1).
English (EN) (223.86 KB - PDF)
Concept paper on the need for revision of guideline on clinical investigation of medicinal products for the treatment of multiple sclerosis
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.
English (EN) (134.64 KB - PDF)
Document history - Revision 1
Guideline on clinical investigation of medicinal products for the treatment of multiple sclerosis - Revision 1
English (EN) (205.8 KB - PDF)
Overview of comments received on draft guideline on multiple sclerosis
English (EN) (57.4 KB - PDF)
Draft guideline on clinical investigation of medicinal products for the treatment of multiple sclerosis - Revision 1
English (EN) (123.26 KB - PDF)
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