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Prescription medicines & biologicals: new registrations
TGA publishes information on new prescription medicines and biologicals as they are approved. This includes entirely new medicines (termed 'new chemical or biological entities'), extended uses ('extensions of indications') or new combinations of already registered medicines, and new generic or biosimilar medicines. Once approved, these medicines and biologicals are added to the Australian Register of Therapeutic Goods (ARTG) and are available for supply in Australia to be prescribed by healthcare professionals for specific indications. The decision to approve these medicines follows a comprehensive review by TGA scientists and clinicians on the quality, safety and efficacy of the proposed use of the medicine.
Details of registrations of new prescription medicines and biologicals are below – please select according to category. Please note that the trade name, active ingredient, and sponsor for each medicine reflect the information initially entered in the ARTG at the time of registration, and may change at a later date. Please consult the ARTG for full information in relation to these products, including full indications.
- New chemical or biological entities
- Extended uses or new combinations of already registered medicines
- New generic medicines or biosimilar medicines
- New biologicals
Orphan drug: sponsors receive a fee waiver to help bring medicines for a small population to market
Priority review: involves faster TGA evaluation of vital and life-saving medicines for which a complete data dossier is available
Provisional registration: involves early access to vital and life-saving medicines through time-limited registration
First generic: first TGA approval of a medicine that contains the same active ingredient as an existing medicine and is bioequivalent to that medicine