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Applications for orphan drug designation

3 March 2016

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'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:

Medicines that have been designated as orphan drugs by the TGA can be found on our web page for designated orphan drugs.

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