European Medicines Agency invites feedback on the draft guideline on clinical investigation of medicinal products for the treatment of multiple sclerosis

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09/10/2012

European Medicines Agency invites feedback on the draft guideline on clinical investigation of medicinal products for the treatment of multiple sclerosis

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a draft guideline on clinical investigation of medicinal products for the treatment of multiple sclerosis. The draft guideline is being released for a six-month public consultation period. The Agency invites comments from its stakeholders.

The guideline is intended to provide guidance for the evaluation of medicines for the treatment of multiple sclerosis, with a particular focus on treatments aimed to modify disease progression. In addition, some remarks are made concerning the treatment of relapses, repair and restoration of functioning.

This draft guideline is a revision of the guideline on clinical investigation of medicinal products for the treatment of multiple sclerosis (CPMP/EWP/561/98, revision 1). It covers the latest scientific developments with regard to treatment targets and patient populations. It also includes guidance on types of data needed in children and adolescents.

Stakeholders are asked to provide comments using this template. Completed feedback forms should be sent to cnswpsecretariat@ema.europa.eu.

The deadline for comments is 9 April 2013.

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