189 results
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Proposed GMP exemption for certain bacteriophage manufacture
The purpose of this consultation is to seek feedback on potential changes to the Therapeutic Goods Regulations 1990 applying to manufacturing of certain bacteriophage therapy products (BTPs) in Australia. Bacteriophages can present a potentially life-saving therapeutic option in the treatment of multidrug-resistant infections. However, it is still considered an experimental therapy and there are no TGA approved BTPs and no Good Manufacturing Practice (GMP) licensed... MoreClosed 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 -
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... MoreClosed 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
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 committed to improve how medical devices are regulated by internationally aligning our regulatory framework (wherever possible) and to participate in the ... MoreOpened today
189 results.
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