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From labs to shelves: EMA’s new booklet explains how drugs are developed and marketed in the EU

 

The European Medicines Agency (EMA) has published a booklet describing the journey of a medicine for human use authorised through EMA, from initial research to discussions on patient access to medicines across the EU. The booklet’s title is »From laboratory to patient: the journey of a centrally authorised medicine» and can be accessed here.

In particular, this useful informative guide describes how EMA supports medicine development by providing scientific advice and how it assesses a medicine’s benefits and risks once it receives an application for marketing authorisation, including details on scientific advice, medicins’ evaluation and discussion at national level on access and pricing.

All the steps involved in these processes, including the involvement of patients, healthcare professionals and other external experts, as well as the principles guiding the scientific discussions are outlined.