European Medicines Agency guideline and response

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European Medicines Agency guideline and response

Post by Heta K. Pukki on Fri 23 Sep - 19:30

The European Medicines Agency published in March 2016 a draft guideline for European researchers developing medications that target autism. The draft can be found here:

http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001155.jsp&mid=WC0b01ac0580034cf5

A response signed by three autistic-led organisations (Finnish, Swedish and Estonian) and individual representatives from four more organisations (Scottish, Irish and French) has been submitted to the EMA.

The response is in the attached file. EMA has not announced when the final guideline will be published, or where the responses will be displayed. The form stated that all the information would be public. We are looking forward to seeing if any of the concerns expressed in the response will be reflected in the final guideline.
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Heta K. Pukki
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