Clinical development of medicinal products for the treatment of autism spectrum disorder (ASD)

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Current version

Draft guideline

Reference numberEMA/CHMP/598082/2013
Published04/03/2016
Effective from 
KeywordsAutism spectrum disorder, paediatric population, adults
DescriptionThis document provides guidance on diagnostic criteria, definition of target treatment populations, efficacy and safety criteria for clinical trials intended to establish the efficacy and safety of treatments for autism spectrum disorder. It addresses specific age-category problems (childhood versus adulthood), and the need for comparative studies.


Document history

First version

Current version

Draft guideline



Concept paper

Published: 04/03/2016

Deadline for comments: 31/08/2016


Published: 03/04/2013


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