EMA consultation

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

The European Medicines Agency has released, for public consultation, a draft best practice guidance for pilot European Medicines Agency health technology assessment parallel scientific advice procedures.

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.

The present document sets out the best practice for all parties, including HTABs, EMA and Applicants undertaking an EMA HTA Parallel Scientific Advice procedure under this pilot. This best practice guide highlights ideal timelines and actions for each party.

The document open for consultation is available by clicking here.

Please see thefollowing link for consultation questions: https://adobeformscentral.com/?f=WIJldoXFmz7BsTWjUwOiDA.

Please note that the deadline for responses for this best practice guidance is 14 July 2014.

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