Consultations

The TGA is seeking comments on the proposed fees and charges for the 2021-22 financial year. Closing date: 17 March 2021

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 4-5 November 2020 meetings of the Advisory Committee on Medicines Scheduling (ACMS) and the Advisory Committee on Chemicals Scheduling (ACCS).

TGA is seeking feedback on a proposal to streamline how information about certain therapeutic goods formulations is entered into TGA electronic systems when seeking market approval. Closing date: 24 February 2021

A submission summary on the Australian Regulations definition of CCS consultation is available on our consultation hub

A further update by the TGA on the proposed reforms to medicinal cannabis, labelling and packaging requirements.

Proposed amendments to the Poisons Standard. Closing date: 27 January 2020

The closing date for this consultation has been extended until 24 December 2020

The TGA (together with all other working group members) invite interested parties to comment on the document. Closing date: 11 December 2020

Outcome of the Proposed enhancements to adverse event reporting for medical devices consultation paper.

This consultation is for an interim decision to amend the scheduling of nicotine in the current Poisons Standard, following advice sought at the 23 June 2020 meeting of the Advisory Committee on Medicines and Chemicals Scheduling in joint session (Joint ACMS-ACCS #25, June 2020).

This consultation is for interim decisions made in relation to applications and delegate initiated proposals to amend the scheduling in 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).

Consultation: Permissible ingredients annual changes 2020-21

The Secretary invites public submissions on scheduling proposals. Closing date: 28 September 2020

The Therapeutic Goods Administration (TGA) is seeking feedback on proposed requirements for serialisation and the use of data matrix codes on the labels of certain medicines in the Australian supply chain.

Draft IMDRF document. Closing date: 26 May 2020

The Secretary invites public submissions on scheduling proposals referred to the June 2020 meeting of the Joint ACMS-ACCS. Closing date: 22 May 2020

Consultation extension. Closing date: 18 May 2020

The TGA is seeking feedback for the Scope Regulated Software based products. Closing date: 13 May 2020

Draft IMDRF document. Closing date: 9 May 2020

The Secretary invites public submissions on scheduling proposals referred to the March 2020 meetings of the ACMS, the ACCS, and the Joint ACMS-ACCS. Closing date: 10 February 2020

The Secretary invites public submissions on scheduling proposals referred to the March 2020 meeting of the Joint ACMS-ACCS. Closing date: 10 February 2020

Consultation on proposed adoption or non-adoption of EU and ICH guidelines. Closing date: 7 Feb 2020

The TGA is seeking comments from interested parties on an update to guidance for the Export of therapeutic goods from Australia.

TGA is seeking comment from interested parties on proposed standards for faecal microbiota transplant (FMT) products in Australia. This is a new area of regulation for TGA from 2020.

The closing date of this consultation has been extended. Closing date: 6 December 2019