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191 results

  • 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... More
    Opened 23 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 ... More
    Opened 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... More
    Opened 19 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... More
    Opened 18 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. More
    Opened 17 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... More
    Opened 16 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... More
    Closed 10 December 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... More
    Opened 5 December 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.... More
    Opened 25 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... More
    Opened 24 November 2025

  • 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... More
    Closed 13 November 2025

  • Consultation: Provisions to Regularise the Technical Master File (TMFs) and Type II Plasma Master File (PMFs) Processes

    The Therapeutic Goods Administration (TGA) is seeking industry feedback on proposed amendments to strengthen the legislative framework for Technical Master Files (TMFs) for blood and blood components, and Plasma Master Files (PMFs) for Type II plasma-derived products. The proposed changes aim to clarify regulatory requirements, reinforce existing practices, and ensure the legislation reflects the original policy intent. Your input is essential to help ensure the... More
    Closed 11 November 2025

  • Consultation: Product Information as a package insert - consumer administered injectables

    Product Information (PI) as a package insert in non-HCP injectable products The Therapeutic Goods Administration (TGA) is seeking feedback on the current usage of paper information included with injectable medicines. This consultation aims to understand whether the paper copy of the Product Information (PI) document is helpful for patients and carers when it is included in the packaging of injectable medicines that they administer themselves. What is a PI? The Product... More
    Closed 7 November 2025

  • Application to amend the Poisons Standard (March 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 March 2026... More
    Closed 7 November 2025

  • Public consultation on proposed amendments to the Poisons Standard - ACMS, ACCS & Joint ACMS-ACCS, NOVEMBER 2025

    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 NOVEMBER 2025 meetings of the Advisory Committee on Medicines Scheduling (ACMS) , the Advisory Committee on Chemicals Scheduling (ACCS) and the Joint Meeting of ACMS and ACCS. The closing date for this consultation is... More
    Closed 17 October 2025

  • Reprocessing and remanufacturing of medical devices

    The TGA is developing guidance documents on the therapeutic goods regulatory requirements for reprocessing and remanufacturing of medical devices. This has been developed in response to queries from two key stakeholder groups: manufacturers and sponsors of reusable and remanufactured medical devices on compliance with regulatory requirements procurement teams, healthcare facilities and healthcare professionals involved in acquiring and using reprocessed and remanufactured... More
    Closed 13 October 2025

  • Consultation: Proposed TGA Annotations to ICH E6(R3) Guideline for Good Clinical Practice (GCP): Principles and Annex I and 12-month Transition Period

    This consultation invites feedback on proposed TGA annotations to ICH E6(R3) Guideline for Good Clinical Practice (GCP): Principles and Annex I and 12-month transition period. On 6 January 2025, the International Council for Harmonisation (ICH) endorsed the third revision (R3) of the ICH Guideline for conducting clinical trials titled ICH E6(R3) Guideline for GCP . This update addresses changes in trial design and technological innovations, and strengthens a proportionate, risk-based... More
    Closed 10 October 2025

  • Consultation: Reviewing the safety and regulatory oversight of unapproved medicinal cannabis products

    Reviewing the safety and regulatory oversight of unapproved medicinal cannabis products The purpose of this consultation paper is to gather information on stakeholders’ experiences, observations and knowledge of the use of unapproved medicinal cannabis products. Information obtained will inform regulatory reform options. The closing date for this consultation is 23.59 AEST on 07 OCTOBER 2025. All submissions received by the deadline, will be considered by... More
    Closed 7 October 2025

  • Digital Mental Health Tools Regulatory Environment Survey

    There is growing interest in using software and artificial intelligence (AI) in healthcare delivery, including where it is used to support people with mental health conditions. The Therapeutic Goods Administration (TGA) is reviewing the regulations that apply to software-based medical devices – including digital mental health tools (DMHTs) – that are used to screen, diagnose, monitor and/or treat patients experiencing mental health conditions. We are seeking... More
    Opened 7 October 2025

  • Public consultation on proposed amendments to the Poisons Standard in relation to homosalate, oxybenzone and benzophenone - Joint ACMS-ACCS #41, September 2025

    Scheduling amendments referred to the joint expert advisory committee on medicines and chemicals scheduling This consultation is for Delegate initiated proposals to amend the Poisons Standard in relation to 2 sunscreen ingredients (homosalate and oxybenzone) and one impurity/degradant (benzophenone). The Delegate is seeking public comments on the proposed amendments for further consideration at the joint meeting of the Advisory Committee on Medicines Scheduling (ACMS) and... More
    Closed 12 August 2025

  • Public consultation on interim decision to amend the Poisons Standard in relation to pyridoxine, pyridoxal or pyridoxamine (vitamin B6)

    Interim decision on proposed amendments to the Poisons Standard in relation to pyridoxine, pyridoxal or pyridoxamine (vitamin B6) This consultation is for an interim decision made in relation to pyridoxine, pyridoxal or pyridoxamine (vitamin B6) discussed at the NOVEMBER 2024 meeting of the Advisory Committee on Medicines Scheduling (ACMS) . The interim decision can be accessed through the link below. A summary of the decision is available on the consultation page for your... More
    Closed 27 July 2025

  • Application to amend the Poisons Standard (November 2025)

    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... More
    Closed 18 July 2025

  • Adoption of International Scientific Guidelines in Australia R02-2024

    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 international... More
    Closed 30 June 2025

  • Public consultation on proposed amendments to the Poisons Standard in relation to somatrogon, lonapegsomatropin and somapacitan, ACMS, June 2025

    Scheduling amendments referred to expert advisory committee This consultation is for delegate initiated proposals to amend the Poisons Standard. The scheduling amendments and any submissions received will be considered at the JUNE 2025 meeting of the Advisory Committee on Medicines Scheduling (ACMS) . The closing date for this consultation is close of business 13 JUNE 2025. All submissions received by the deadline will be considered by the delegate... More
    Closed 13 June 2025

  • Consultation: Proposed changes to the IVD medical device classifications and definitions

    The Therapeutic Goods Administration (TGA) is seeking stakeholders’ feedback on proposed changes to the IVD medical device classifications and definitions. This consultation aims to confirm views on aligning classification rules, principles, and definitions with the European Regulation 2017/746 for in vitro diagnostic medical devices (IVDR) where appropriate. The proposed changes include: • Australian classification rules and principles that classify... More
    Closed 23 May 2025

  • Public consultation on proposed amendments to the Poisons Standard - ACMS & Joint ACMS-ACCS, June 2025

    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 June 2025 meeting of the Advisory Committee on Medicines Scheduling (ACMS) and the Joint Meeting of ACMS and the Advisory Committee on Chemicals Scheduling (ACCS) . The closing date for this consultation is close of... More
    Closed 21 May 2025

  • Public consultation on interim decisions to amend the Poisons Standard - ACMS, ACCS & Joint ACMS-ACCS November 2024

    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 NOVEMBER 2024 meetings of the Advisory Committee on Medicines Scheduling (ACMS) and the Joint meeting of the 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... More
    Closed 4 April 2025

  • Public consultation on interim decision to amend the Poisons Standard in relation to IV potassium

    Interim decision Public consultation on the interim decision on scheduling of intravenous potassium (IV potassium) has been resumed i n recognition of the broad impact of the proposed changes and to allow more stakeholders to submit their responses. The closing date for this consultation is close of business 18 March 2025. All submissions received by the deadline will be considered by the delegate before they make a final decision. The interim decision under consultation... More
    Closed 18 March 2025

  • Application to amend the Poisons Standard (June 2025)

    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 June 2025... More
    Closed 7 March 2025

  • Public Consultation - TGA fees and charges proposal 2025-26

    Consultation: Fees and Charges Proposal 2025-26 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 2025-26 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,... More
    Closed 28 February 2025
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