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. 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 authorisation.
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.
This initiative aims to improve public understanding of how EMA procedures are run. We encourage you to make use of this information and disseminate it as widely as possible.
Please note: EMA moved its offices to The Netherlands.
The new address is:
European Medicines Agency
Domenico Scarlattilaan 6 | 1083 HS Amsterdam | The Netherlands