This consultation is to obtain feedback in relation to proposals to provide clarity on residual claims for disinfectants.
The Therapeutic Goods Administration (TGA) has received a number of enquiries relating to residual activity claims for disinfectants, including whether...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
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 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 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 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
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
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 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
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 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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The Therapeutic Goods Administration (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.
Specifically, we propose to discontinue entering certain types...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 the...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
Scheduling amendments referred to expert advisory committee
This pre-meeting consultation is for applications and delegate initiated proposals to amend the scheduling in the Poisons Standard for certain substances. The scheduling amendments and any submissions received will be...More
The Department of Health invites submissions in relation to options for reforms and improvements to the Prostheses List.
In 2017, the Australian Government entered into the Strategic Agreement with the Medical Technology Association of Australia (MTAA). Through the MTAA Agreement, a...More
The Department of Health through the Therapeutic Goods Administration (TGA) is seeking comments from interested parties on a review of the regulatory processes for the manufacturing, labelling and packaging of medicinal cannabis products.
The Therapeutic Goods Administration (TGA) is...More
On 6 October 2020, the Australian Government announced the second wave of reforms to private health insurance with the aim of improving the affordability, value, and attractiveness of private health insurance, particularly for younger Australians [Budget Paper No.2 - Budget Measure: Supporting...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 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) 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
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
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 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) 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) 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
Reform of the food regulatory system
In March 2020, the Australian New Zealand Ministerial Forum on Food Regulation (the Forum) endorsed an implementation plan for an ambitious reform agenda for the food regulatory system aimed at ensuring the system remains strong, robust and agile into...More
The Australian Government welcomes the Productivity Commission (PC) Inquiry Report on Mental Health. It provides 21 recommendations with 103 associated actions spanning five key themes:
prevention and early help for people;
improve people’s experiences with mental...More