Draft best practice guidance for pilot European Medicines Agency health technology assessment parallel scientific advice procedures

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Document details

Download document Draft best practice guidance for pilot European Medicines Agency health technology assessment parallel scientific advice procedures
Reference number EMA/109608/2014
Status draft: consultation closed
First published 2014-05-08
Last updated 2014-05-08

Summary

As the first step to market access, a new medicine requires a marketing authorisation from a medicines regulatory agency. The second step prior to enabling patient access to a new therapeutic option increasingly involves the assessment of its usefulness to the healthcare system that lies with a payer or healthcare-guidance organisation, and the Health Technology Assessment Bodies (HTABs) that advise them.