EU orphan drug roll out: navigating regulatory challenges
Entering the European rare drug market is a big step for any US biotech firm. It’s a step you shouldn’t take without first reading our essential guide to understanding regulatory challenges within the EU.
To help you to navigate the complexities of EU regulations and distribution, our guide covers these key topics to help you thrive in the European market:
- Requirements from European Medicines Agency (EMA)
- The process of gaining ‘orphan designation’
- Negotiating with individual EU countries
- The importance of early phase engagement
- Product packaging issues