The content on this page and other TGA archive pages is provided to assist research and may contain references to activities or policies that have no current application. See the full archive disclaimer.
Applications for orphan drug designation
'Orphan drugs' are often developed to treat small and very specific patient populations who suffer from rare diseases and conditions.
The application and evaluation fees for orphan drugs can be waived to:
- help reduce their development costs
- facilitate their access to the Australian marketplace
However, a medicine needs to be:
- designated by us as an orphan drug before an application can be accepted to register it on the Australian Register of Therapeutic Goods (ARTG)
- evaluated for quality, safety and efficacy in the same way as other registered medicines.
Medicines that have been designated as orphan drugs by the TGA can be found on our web page for designated orphan drugs.