Orphan designation: research and development
The European Medicines Agency provides support, including regulatory guidance and incentives, for the research and development of medicines for rare diseases in the European Union (EU).
In this section
- Orphan incentives
- Applying for orphan designation
- Activities after orphan designation
- Submitting annual reports on medicine development
- Changing the name or address of a sponsor
- Removing an orphan designation
- Transferring a designation to a new sponsor
In other sections
Sponsors of designated orphan medicines should also consider the regulatory information in the sections below: