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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.

symbol denoting an orphan drug

Orphan drug: sponsors receive a fee waiver to help bring medicines for a small population to market

symbol denoting a priority determination

Priority review: involves faster TGA evaluation of vital and life-saving medicines for which a complete data dossier is available

symbol denoting a provisional registration

Provisional registration: involves early access to vital and life-saving medicines through time-limited registration

symbol denoting a first generic

First generic: first TGA approval of a medicine that contains the same active ingredient as an existing medicine and is bioequivalent to that medicine