197 results
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Targeted consultation on proposed changes to the regulation of medicinal maggots
The Therapeutic Goods Administration (TGA) requests your feedback on proposed regulatory changes to ensure the legislation governing medicinal maggots is fit-for-purpose. Specifically, this consultation seeks feedback on the following proposals: (1) a 2-year transitional licensing exemption from the operation of Part 3-3 of the Therapeutic Goods Act 1989 (the Act) in relation to the manufacture of medicinal maggots (referred to in this paper as the Good Manufacturing... MoreOpened 13 November 2025 -
Adoption of International Scientific Guidelines in Australia R01-2025
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 consultation to ensure the international scientific guideline is consistent with prevailing requirements in Australia. The TGA has approximately 370 current adopted... MoreOpened 24 November 2025 -
Digital Scribes - Stakeholder Form
The Therapeutic Goods Administration (TGA) is Australia’s regulatory authority for therapeutic goods and forms part of the Australian Government Department of Health, Disability and Ageing. We are responsible for regulating medical devices, including software as a medical device, in accordance with Australian law. We are reviewing the functionality of digital scribes supplied in Australia to understand their functionality and to consider how the regulatory framework may apply.... MoreOpened 25 November 2025 -
Application to amend the Poisons Standard (July 2026)
This is the new version of the form: Application to amend the Poisons Standard. Help us improve it by providing your feedback via email to the Scheduling Secretariat . This form contains notes on each page to help you navigate through the sections. You can expand the ‘More information’ tabs for further details. Please note in accordance with the Scheduling committees meeting dates and decisions timeframes published on the TGA website, applications for the July 2026... MoreOpened 5 December 2025 -
UDI Consent to Supply approach and fees
In March 2025 the Therapeutic Goods (Medical Devices) Regulations 2002 were updated to include Unique Device Identification (UDI) requirements. Mandatory compliance is set to begin on 1 July 2026 for Class III and IIb medical devices, followed by lower device classes over later years . Compliance with UDI requirements is a significant undertaking as it impacts manufacturing processes, quality management systems, IT systems and business processes. The... MoreOpened 10 December 2025 -
Consultation on proposed changes to labelling of medicines supplied in Australia
Medicine labels give health professionals and consumers important information to help use medicines safely and correctly. If labels are hard to read or understand, medication errors are more likely. Medicines prescribed or given by a health professional have different risks and need different information on the label compared to medicines chosen off the shelf by a consumer. Because of this, there are two labelling standards in Australia that set out what information must... MoreOpened 16 December 2025 -
Digital Mental Health Tools User Survey
The number of people using software, including artificial intelligence (AI), to diagnose, manage and treat mental health conditions is growing. Apps, websites, and computer programs designed for these purposes are referred to as digital mental health tools. The Therapeutic Goods Administration (TGA) is reviewing how these tools are regulated in Australia to make sure these products are safe. MoreOpened 17 December 2025 -
Public consultation on interim decisions to amend the Poisons Standard - ACCS & Joint ACMS-ACCS - MARCH, 2025
Interim decisions regarding substances discussed at the expert advisory meetings. This consultation is for interim decisions made in relation to substances that were discussed at the March 2025 meetings of the Advisory Committee on Medicines Scheduling (ACMS) and the Advisory Committee on Chemicals Scheduling (ACCS) . Kindly note that the interim decisions published below may differ from the initial proposal. Please read through the proposed interim decisions which can be... MoreOpened 18 December 2025 -
Consultation: Conformity Assessment Procedures for Medical Devices | Proposed Amendments
We are aware of recent proposed changes to the European regulations. Those proposed changes will be considered with the responses to this consultation. The TGA has been systematically reviewing the way medical devices are regulated. This has been guided by An Action Plan for Medical Devices which is a three-part strategy to strengthen Australia’s regulatory system while continuing to be patient focused and have greater transparency. The Australian Government is also... MoreOpened 19 December 2025 -
Public consultation on the interim decision to amend the Poisons Standard in relation to adrenaline - ACMS, June 2025
Interim decision on proposed amendments to the Poisons Standard in relation to adrenaline. This consultation is for an interim decision made in relation to adrenaline that was discussed at the JUNE 2025 meetings of the Advisory Committee on Medicines Scheduling (ACMS) . Kindly note that the interim decision published below may differ from the initial proposal. Please read through the proposed interim decisions which can be accessed through the links below and are available on... MoreOpened 19 December 2025 -
Public consultation on proposed amendments to the Poisons Standard - ACMS, ACCS & Joint ACMS-ACCS, MARCH 2026
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 MARCH 2026 meetings of the Advisory Committee on Medicines Scheduling (ACMS) and the Advisory Committee on Chemicals Scheduling (ACCS) and the Joint meeting of ACMS and ACCS. The closing date for this consultation is... MoreOpened 23 December 2025 -
Consultation: Improved sharing of information about medical devices | Proposed amendments relating to transparency of disruptions to supply of a medical device
We want your feedback on the proposed changes to improve transparency about disruptions to the supply of medical devices. The proposed changes are intended to help in monitoring, assessing and responding to potential and actual supply disruptions. These changes align with the intent of An Action Plan for Medical Devices to provide more information to patients about the medical devices they use. What this consultation is about The consultation... MoreOpened 7 January 2026 -
Public Consultation - TGA fees and charges proposal 2026-27
Consultation: Fees and Charges Proposal 2026-27 The Therapeutic Goods Administration (TGA) is conducting a public consultation to provide industry and other interested stakeholders with an opportunity to comment on the TGA’s proposed fees and charges for the 2026-27 financial year. Specifically, we are seeking feedback on the potential impact/s of the proposed changes to fees and charges prior to seeking approval from the Government for any changes. The TGA,... MoreOpened 30 January 2026 -
Public Consultation - Annual Charge Exemption (ACE) Scheme Compliance Program Updates
Annual Charge Exemption Scheme The Annual Charge Exemption (ACE) scheme commenced on 1 July 2015. It provides an exemption from paying Therapeutic Goods Administration (TGA) annual charges until a therapeutic good covered by an entry on the Australian Register of Therapeutic Goods (ARTG) begins generating turnover. The scheme allows sponsors to enter their goods in the ARTG in advance of marketing without incurring an annual charge, until the goods are taken to the market. ... MoreOpened 23 February 2026 -
Personalised medical devices consumer survey
The Therapeutic Goods Administration (TGA) regulates medical devices to ensure they are safe and work as intended. We regularly review and update our rules to keep pace with technology and protect patients and consumers. We are currently reviewing personalised medical devices. These are devices designed and made to suit you personally. This is often done by taking a scan or a physical impression of a body part, and making the device based on these. Examples of... MoreOpened 16 March 2026 -
Improvements to the regulation of sunscreens in Australia
Seeking feedback on improvements to the regulation of sunscreens in Australia Recent international and domestic developments have highlighted a number of matters in relation to the current regulation of sunscreens. Given Australia has the highest rates of skin cancer and melanoma in the world with around 2,000 people dying each year, it is critical that the regulatory settings are appropriate to ensure consumer confidence in sunscreens. The TGA is seeking feedback... MoreOpened 26 March 2026 -
Application to amend the Poisons Standard (NOVEMBER 2026)
This is the new version of the form: Application to amend the Poisons Standard. Help us improve it by providing your feedback via email to the Scheduling Secretariat . This form contains notes on each page to help you navigate through the sections. You can expand the ‘More information’ tabs for further details. Please note in accordance with the Scheduling committees meeting dates and decisions timeframes published on the TGA website, applications for the NOVEMBER... MoreOpened 17 April 2026
197 results.
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