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

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Current version

Draft guideline
Currently under revision - see below

Reference numberEMA/CHMP/598082/2013
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

Adopted guideline

Draft guideline

Concept paper

Published: 21/11/2017
Effective from: 01/06/2018

Published: 04/03/2016

Published: 03/04/2013

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