Applying for a prescription medicine via orphan drug designation

Orphan drug designation allows for a waiver of the application and evaluation fees to register drugs that treat rare medical conditions.

New prescription medicines for medical conditions that affect fewer than 5 in 10,000 people are eligible for orphan drug designation.

We look at the clinical data and assess applications on a case-by-case basis. Eligibility criteria apply.

An orphan drug designation is valid for 6 months. During this time, you may apply to register your medicine as an orphan drug.

You may apply for a 6-month extension to your designation, subject to our approval.

What to consider before applying

Before applying to register your prescription medicine, you must obtain an orphan drug designation.

Once you have been granted an orphan drug designation, you can apply for registration via your selected pathway.

You will need to show evidence of your orphan drug designation to receive a waiver of the fees.

An orphan drug designation does not guarantee registration.

To apply for orphan drug designation, you will need:

TGA client ID number
access to the TGA Business Services portal. See: TGA Business Services: getting started with TGA.

To see what medicines have already been granted orphan designation, see Prescription medicines determinations and designations.

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