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:

• Applying for marketing authorisation: orphan medicines
• Market exclusivity