Consultations

We sought feedback on the draft guidance ‘Boundary and combination products - medicines, medical devices, and biologicals’. Read about the outcome of this consultation.

The TGA is seeking feedback on whether certain international scientific guidelines should be adopted.

The TGA is considering regulatory options to allow advertisers, including product sponsors, to make references to the TGA in advertising (including on product labels).

Closing date: 14 October 2022

The TGA is seeking feedback on the third consultation paper published by the TGA relating to the Australian implementation of a Unique Device Identification (UDI) System for medical devices.

Public consultation on the Product Information (PI) as a package insert in boxed injectable products.

Proposed amendments to the Poisons Standard. Closing date: 29 September 2022

The (TGA) is seeking feedback on proposed regulatory changes to strengthen safety oversight of clinical trials for medical devices.

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 15-16th March 2022 meetings of the Advisory Committee on Medicines Scheduling (ACMS) and the Advisory Committee on Chemicals Scheduling (ACCS).

Closed: 15 September 2022. Consultation results are now available on the TGA Consultation Hub

The Therapeutic Goods Administration (TGA) is seeking feedback on whether or not certain international scientific guidelines should be adopted.

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 Government’s reforms. The TGA has issued this survey as part of the Government’s reform program.

Proposed amendments to the Poisons Standard. Closing date: 27 May 2022

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 Advisory Committee on Medicines Scheduling (ACMS) and the Advisory Committee on Chemicals Scheduling (ACCS).

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 Medicines Scheduling (ACMS).

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 Advisory Committee on Chemicals Scheduling (ACCS).

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 Medicines Scheduling (ACMS) and the Advisory Committee on Chemicals Scheduling (ACCS).

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 Advisory Committee on Chemicals Scheduling (ACCS).

The TGA is seeking feedback on the updated 'Listed medicines evidence guidelines - How to demonstrate efficacy of listed medicines'. Closing date: 1 April 2022

Consultation seeking feedback on the repurposing of medicines to inform the development of options for Government consideration closed 1 April 2022

The TGA is seeking feedback on a proposed priority pathway for assessment of certain novel and life-saving biologicals. Closing date: 28 March 2022

The TGA is conducting a public consultation to provide interested stakeholders with an opportunity to comment on options for the TGA's proposed fees and charges for the 2022-23 financial year. Closing date: 7 March 2022

The TGA is seeking feedback on whether certain international scientific guidelines should be adopted. Closing date: 20 February 2022

The TGA is seeking feedback from sponsors on improving their access to medicine adverse event data. Closing date 18 February 2022

The TGA is seeking feedback on a proposal to improve patient access to critical medicines in acute-care settings. Closing date: 7 February 2022