Useful info

In this section useful background information related to Orphan Drug Development is provided.

Also, please feel free to visit/join our LinkedIn group: OrphanXChange, to exchange and discuss topics in relation to Orphan Drug Development.

Click here for an overview of the incentives of an Orphan Designation in Europe and the US.

Downloads:

EU regulation on orphan medicinal products (PDF)

Guideline on the format and content of applications for designations as orphan (PDF)

Fee reductions for designated orphan medicinal products (PDF)

COMP paper on medicinal plausability (PDF)

External websites:

Food and Drug Administration (FDA)

European Medicines Agency (EMA)

Eurordis (patient organisation alliance)