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

Current version

PDF icon<b>Draft guideline</b>
Currently under revision - see below

Reference numberEMA/CHMP/598082/2013
Published04/03/2016
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

PDF iconAdopted guideline

PDF iconDraft guideline


PDF iconConcept paper

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

Published: 04/03/2016


Published: 03/04/2013


Related content


How useful was this page?

Add your rating