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...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
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
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
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
The Therapeutic Goods Administration (TGA) is seeking comments from interested parties on proposed minor changes to advisory statement requirements for labels of over the counter (OTC) medicines containing chlorhexidine, hydrocortisone or ibuprofen , for inclusion in the ...More
The Therapeutic Goods Administration (TGA) is seeking comments from interested parties on proposed advisory statements for labels of over the counter (OTC) medicines containing melatonin, for inclusion in the Required Advisory Statements for Medicine Labels (RASML) . The proposal to include...More
The Therapeutic Goods Administration (TGA) is seeking comments from interested parties on proposed advisory statements for labels of over the counter (OTC) medicines containing mometasone in dermal and nasal spray preparations , for inclusion in the Required Advisory Statements...More
The Therapeutic Goods Administration (TGA) is seeking comments from interested parties on proposed new advisory statements for labels of over the counter (OTC) medicines containing triptans (sumatriptan, zolmitriptan, rizatriptan, eletriptan) , for inclusion in the Required...More
It is important that patients have access to information about their implanted medical devices.
Globally, the requirements for medical device patient information materials vary. Implementation of requirements for these materials in Europe is occurring now through to 2024, whilst in...More
Scheduling amendments referred to expert advisory committee
This consultation is for an interim decision made in relation to an application to amend the Poisons Standard, following advice sought at the 17-18 March 2021 meetings of the Advisory Committee on Medicines Scheduling (ACMS) and...More
This form should be used by manufacturers and sponsors of medical devices that record patient images or that are anatomical models, and that will be reclassified by the amendments to the Therapeutic Goods (Medical Devices) Regulations 2002 from 25 February 2021. Devices are eligible for...More
From 25 February 2021, a new framework for regulating personalised medical devices will commence. Comprehensive guidance about the framework can be found at: https://www.tga.gov.au/resource/personalised-medical-devices-including-3d-printed-devices
The Therapeutic Goods...More
Please note this form closes at 11.59pm on 24 August 2021
This form should be used by sponsors and manufacturers of software-based medical devices that will need to be included in the ARTG at a higher classification as a result of the amendments to the Therapeutic Goods (Medical Devices)...More
As part of the TGA Digital Transformation, the public search of the Australian Register of Therapeutic Goods (ARTG) is under review so we can better meet your needs. The ARTG is a register of therapeutic goods that can be lawfully supplied in Australia.
We welcome your feedback on 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 17-18 March 2021 meetings of the Advisory Committee on...More
In early 2019 the Therapeutic Goods Administration (TGA) conducted a public consultation seeking feedback on a proposal to introduce new classification rules for medical devices composed of substances that are intended to be introduced into the human body through a body orifice, or applied...More
On 25 February 2021, changes to the Therapeutic Goods (Medical Devices) Regulations 2002 (‘the Regulations’) commenced to introduce a new regulatory framework (the Framework) for medical devices that are designed and manufactured for individual patients (otherwise known as 'personalised'...More
The Therapeutic Goods Administration (TGA) is seeking feedback on a proposal to remake some of the legislative instruments relating to human cell and tissue (HCT) products (including blood and blood components), which sunset in October 2021.
We are seeking feedback to make sure the...More