No guideline is available for the development of medicines for the treatment of autism spectrum disorders (ASDs). Guidance is needed especially with regard to diagnostic criteria, definition of target treatment populations, efficacy criteria, specific age-category problems (childhood versus adulthood), and the need for comparative studies. Also because ASDs are life-long conditions, new treatments need in principle to be evaluated in all age groups and there is a need for long-term safety data.

 

 

Download document Concept paper on the development of medicinal products for the treatment of autism spectrum disorder
Reference number EMA/CHMP/40896/2013
Status draft: consultation open
First published 03/04/2013
Last updated 03/04/2013
Consultation start date 04/04/2013
Consultation end date 04/07/2013
Email address for submissions cnswpsecretariat@ema.europa.eu

 

Posted on the EMA website on 3 April 2013