Draft concept paper on the development of medicinal products for the treatment of autism spectrum disorder

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Download document Draft concept paper on the development of medicinal products for the treatment of autism spectrum disorder
Reference number EMA/CHMP/40896/2013
Status draft: consultation closed
First published 03/04/2013
Last updated 03/04/2013

Summary

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.