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

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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 open
First published 08/05/2014
Last updated 08/05/2014
Consultation start date 08/05/2014
Consultation end date 14/07/2014
Email address for submissions  

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.