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 4-5 November 2020 meetings of the Advisory Committee on...More
The Australian Government Department of Health invites you to share your views on the proposed approach to making mitochondrial donation available in Australia. The Australian Government wants to introduce mitochondrial donation so this lifesaving technology is made available for families impacted...More
In July 2017 the Legislative and Governance Forum on Gene Technology (the Forum) formally commenced the Third Review (Third Review) of the National Gene Technology Scheme (the Scheme). The initial aim of the Review was to assess the operation of the Scheme with respect to its policy...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 2021-22 financial year. Specifically, we are seeking feedback on the...More
Repurposing is the process of identifying new uses (or ‘indications’) for medicines. In some cases, prescription medicines may have been used ‘off-label’ for many years to treat conditions that they do not have formal regulatory approval (i.e. are not registered) for. Whilst this may...More
This form is to completed if you wish to complete a request for a revalidated service for a client with the Australian Government Hearing Services Program.
Please click the link below to begin your request.
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The Therapeutic Goods Administration (TGA) is seeking comments on a proposed standard for vaporiser nicotine products.
Vaporiser nicotine products are nicotine-containing products intended to be used in vaping devices such as e-cigarettes, e-cigars and other electronic nicotine...More
The Australian Government is undertaking a significant program of reform to 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...More
The Medical Research Future Fund’s (MRFF) Cardiovascular Health Mission (the Mission) was announced as part of the 2019-20 budget to provide $220 million for research to make transformative improvements in cardiovascular health and stroke for all Australians.
An Expert Advisory Panel was...More
The Medical Research Future Fund’s (MRFF) Traumatic Brain Injury Mission (the Mission) was announced as part of the 2019-20 budget to provide $50 million for research to improve patient recovery after Brain injury. It will support projects that predict recovery outcomes, or identify the most...More
The Medical Research Future Fund’s (MRFF) Genomics Health Futures Mission (the Mission) was announced as part of the 2018-19 budget to provide $500 million for research to deliver better testing, diagnosis and treatment.
An Expert Advisory Committee was appointed in April 2019 to provide...More
The Medical Research Future Fund’s (MRFF) Stem Cell Therapies Mission (the Mission) was announced as part of the 2019-20 budget to provide $150 million for research to develop innovative, safe and effective treatments accessible to all Australians who need them.
An Expert Advisory Panel ...More
The Medical Research Future Fund’s (MRFF) Dementia, Ageing and Aged Care Mission (the Mission) was announced in December 2018 to provide $185 million for research to support older people to maintain their health and quality of life as they age, live independently for longer and access quality...More
The Medical Research Future Fund’s (MRFF) Indigenous Health Research Fund (IHRF) was announced in February 2019 to provide $160 million for research to improve the health of Aboriginal and/or Torres Strait Islander people.
An Expert Advisory Panel was appointed in September 2019 to...More
The Australian Government has a clear and bold vision for sport integrity in Australia, and is committed to ensuring Australian sport is appropriately protected in the rapidly evolving sports integrity threat environment .
The reforms announced as part of this package will require...More
The Department of Health administers the Australian Government Hearing Services Program (the program). The program supports the delivery of hearing services to over one million eligible clients through Contracted Service Providers.
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This form should be used by manufacturers and sponsors of medical devices that are eligible for the transition period for custom-made medical devices that will be patient-matched medical devices from 25 February 2021. Devices are eligible for transition if:
the device has been supplied...More
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) 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
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
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
From 25 February 2021, a new framework for regulating software as a medical device will commence. The Regulation of software based medical devices details these changes, and additionally the following guidance documents have also been published to assist users understand the various...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 following site readiness requirements for the AstraZeneca (AZ) COVID-19 vaccine has been developed by the Australian Government in consultation with expert advice from the Australian Technical Advisory Group on Immunisation (ATAGI) and the standards outlined in the Australian...More
Thank you for your interest in becoming accredited as a service provider for the Australian Government Hearing Services Program.
Please click the link below to begin your application.
You may wish to download a PDF of the application form for your information before you proceed....More
Thank you for your interest in becoming registered as an Appointed Supplier for the Australian Government Hearing Services Program.
Please click the link below to begin your application.
You may wish to download a PDF version of the application form before you proceed. Note that we...More
Thank you for your interest in transferring your accreditation as a service provider for the Australian Government Hearing Services Program to another entity.
Please click the link below to begin your application.
You may wish to download a PDF of the application form for your...More
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