Clinical investigation of medicinal products for the treatment of Duchenne and Becker muscular dystrophy

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Current effective version

Adopted guideline

Reference numberEMA/CHMP/236981/2011, Corr. 11
Published21/12/2015
Effective from01/07/2016
KeywordsDuchenne and Becker muscular dystrophy, paediatric population, genetic neuromuscular disorder, molecular diagnosis, motor function, muscle strength
DescriptionThis document provides guidance on the development of any medicinal product for the treatment of Duchenne or Becker muscular dystrophy. It addresses the identification of the target population, study design and choice of efficacy endpoints and safety parameters.


Document history 

First version

Current version

Adopted guideline


Overview of comments


Draft guideline


Concept paper

In operation: 01/07/2016–present


Published: 11/03/2016


Published: 01/03/2013


Published: 08/07/2011


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