Find, share and participate in consultations from the Therapeutic Goods Administration that interest you.
Browse our open consultations below, or search for consultations in the search bar above. Once finalised, decisions will be published under closed consultations.
The Therapeutic Goods Administration (TGA) is seeking feedback on whether or not certain international scientific guidelines should be adopted.
Prior to adopting any international scientific guideline, the TGA undertakes an extensive process of internal and external...More
This form should be used by medical device manufacturers and sponsors that wish to access the transition period for patient-matched medical devices.
Please note: This form is being hosted on a consultation platform, however it is not a consultation and none of the information that you...More
From 1 December 2021, the application for consent to import, supply, or export a medical device that does not comply with the Essential Principles has moved to the TGA Business Services (TBS) portal. The new form will provide stakeholders with a more efficient way of submitting an application to...More
Welcome
You are now on the Australian Unique Device Identification Database ( AusUDID) Sandpit registration page.
You can return to the UDI Hub to view other AusUDID information at any time.
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This notification form is for Australian manufacturers or sponsors of clinical decision support software, that meet the exemption criteria outlined in the Therapeutic Goods (Medical Devices) Regulations 2002 .
The exemption applies to medical devices that are clinical...More
The Australian Government is undertaking a significant program to reform the regulation of therapeutic goods in Australia. As part of the Australian Government Department of Health, the Therapeutic Goods Administration (TGA) regulates therapeutic goods, and is responsible for implementing the...More
Scheduling amendments referred to expert advisory committee
This consultation is for applications and delegate initiated proposals to amend the Poisons Standard. The scheduling amendments and any submissions received will be considered at the June 2022 meetings of the ...More
Scheduling amendments referred to expert advisory committee
This consultation is for interim decisions made in relation to applications to amend the Poisons Standard, following advice sought at the 3-4 November 2021 meetings of the Advisory Committee on Medicines Scheduling (ACMS) and the ...More
Scheduling amendments referred to expert advisory committee
This consultation is for interim decisions made in relation to applications and delegate initiated proposals to amend the Poisons Standard, following advice sought at the 23-25 June 2020 meetings of the Advisory Committee on...More
Prescription medicines have been used ‘off-label’ for a given indication for many years to treat conditions or uses that have not been registered in Australia. Whilst this is often aligned with accepted clinical practice, it can lead to patient inequity as it is applied in an ad hoc manner at...More