Booklet on EMA pre-submission and assessment processes
EMA has published a booklet describing the journey of medicine for human use authorized through EMA, from initial research to discussions on patient access to medicines across the EU. It can be found here.
The booklet describes in particular 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 authorization.
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.