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

This 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.

Keywords: Autism spectrum disorder, paediatric population, adults

Current effective version

Guideline on the clinical development of medicinal products for the treatment of Autism Spectrum Disorder (ASD)

Adopted Reference Number: EMA/CHMP/598082/2013 Legal effective date: 01/06/2018

Document history

Guideline on the clinical development of medicinal products for the treatment of Autism Spectrum Disorder (ASD)

Adopted Reference Number: EMA/CHMP/598082/2013 Legal effective date: 01/06/2018

Draft guideline on the clinical development of medicinal products for the treatment of Autism Spectrum Disorder (ASD)

Draft: consultation closed Consultation dates: 04/03/2016 to 31/08/2016 Reference Number: EMA/CHMP/598082/2013 Summary:

Autism Spectrum Disorder (ASD) is among the most common and varied disorders in paediatric psychiatry. It impacts significantly on social, occupational, or other important areas of functioning, and is a lifelong condition. Although various therapies and interventions are available, few are supported by scientific studies.

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

Draft: consultation closed Consultation dates: 04/04/2013 to 04/07/2013 Reference Number: EMA/CHMP/40896/2013 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.