The Therapeutic Goods Administration (TGA) is seeking feedback on proposed regulatory changes to strengthen safety oversight of clinical trials for medical devices. The changes are:
To increase the degree of regulatory oversight of clinical trials of certain unapproved,...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 15-16th March 2022 meetings of the Advisory Committee on...More
The Therapeutic Goods Administration (TGA) is seeking feedback from interested parties on the proposed low-negligible risk changes to the Permissible Ingredients Determination . The proposed changes address the following issues:
Warning statement requiring healthcare ...More
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
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 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
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
The Therapeutic Goods Administration (TGA) is seeking feedback on a proposed priority pathway for assessment of certain novel and life-saving biologicals .
The proposed 'Priority Review' pathway will align with the pathway in place for medicines and offer a faster formal assessment pathway...More
The Therapeutic Goods Administration (TGA) is seeking feedback on the updated ‘Listed medicines evidence guidelines – How to demonstrate efficacy for listed medicines’ (the Guidelines), which is intended to replace the existing ‘ Evidence guidelines – Guidelines on the evidence...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
The TGA is seeking feedback on how effectively information relating to the results of listed medicine compliance reviews is being conveyed to consumers.
More
The Therapeutic Goods Administration (TGA) is conducting a public consultation to provide industry and other interested stakeholders with an opportunity to comment on options for the TGA’s proposed fees and charges for the 2022-23 financial year. Specifically, we are seeking feedback on the...More
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
The Therapeutic Goods Administration (TGA) monitors the safety of medicines (including vaccines) by collecting and assessing reports of adverse events and taking regulatory action to improve medicine safety. The sponsors of medicines in Australia also have pharmacovigilance responsibilities,...More
The Therapeutic Goods Administration (TGA) is seeking feedback on whether an amendment to the Therapeutic Goods Regulations 1990 is required in order to improve patient access to critical medicines in acute-care settings.
The current regulatory framework does not permit hospital...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 15-17 March 2022 meetings of the ...More
From 19 October 2020, how the TGA engages with the sponsors for post market reviews has changed. A new medical device Post Market Review Compliance Dashboard has been developed in TBS to respond to post market reviews. The new compliance dashboard will provide the sponsors with an efficient...More
The Therapeutic Goods Administration (TGA) is seeking feedback on potential options for the regulation of biological therapeutic goods (biologicals) manufactured in Australia for export only (and not for supply in Australia).
Biologicals are human tissue and cell-derived products...More
The Australian Government is undertaking a significant program of reform to improve the safety, performance, and quality of medical devices in Australia and improve health outcomes for patients who require medical devices. As part of the Australian Government Department of Health, the...More
This form is no longer in use. Please refer to the TGA website to complete an application for consent to import, supply, or export a medical device that does not comply with the Essential Principles.
There are Criminal Offences under S41MA and Civil Penalties under S41MAA of the ...More
This form is no longer in use. Please refer to the TGA website to complete an application for consent to import, supply, or export a medical device that does not comply with the Essential Principles.
There are Criminal Offences under S41MA and Civil Penalties under S41MAA...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 22 June 2021 meeting of the Advisory Committee on Chemicals...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 June 2021 meetings of the Advisory Committee on Medicines...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 June 2021 meetings of the Advisory Committee on Medicines...More
We have extended the timeframe for submissions to this consultation. We will commence analysing submissions from 22 October 2021. However some stakeholders have requested more time to submit their comments, so the capacity to make submissions will remain open until Friday 5 November 2021. We...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 23-24 June 2021 meeting of the Advisory Committee on...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 23-24 June 2021 meeting of the Advisory Committee on...More
Scheduling amendments referred to expert advisory committee
This pre-meeting 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 November 2021...More
ATTENTION: Due to difficulties many of our stakeholders are experiencing in lockdown, the closing date for submissions to this consultation has been extended until Wednesday 29th September 2021 . The outcomes of the consultation will now be anticipated for publication on Wednesday 15th...More