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  • Public consultation on interim decisions to amend the Poisons Standard - ACMS, ACCS & Joint ACMS-ACCS JUNE, 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 JUNE 2024 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
    Closed 18 October 2024

  • Clarifying and strengthening the regulation of Artificial Intelligence (AI)

    Artificial Intelligence (AI) has already made a difference to many lives, providing the potential to solve problems faster, and opening up opportunities to get things done in smarter and better ways. If safely deployed, its development and adoption can improve wellbeing, quality of life and economic growth. At the same time, caution is needed as AI presents a potential to create or amplify harms to individuals, organisations, communities and social cohesion through risks associated with its... More
    Closed 20 October 2024

  • Public consultation on proposed amendments to the Poisons Standard - ACMS, ACCS & Joint ACMS-ACCS, November 2024

    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 2024 meetings of the Advisory Committee on Medicines Scheduling (ACMS) and the Advisory Committee on Chemicals Scheduling (ACCS) . The closing date for this consultation is close of business 22 October 2024. ... More
    Closed 22 October 2024

  • Consultation: Future regulation of assistive technologies

    The TGA is seeking feedback on proposed changes to the regulation of assistive technologies. The TGA is Australia's government authority responsible for evaluating, assessing, and monitoring products that are defined as therapeutic goods including medicines, medical devices and biologicals to help Australians stay healthy and safe. T he current provisions in the Therapeutic Goods (Excluded Goods) Determination... More
    Closed 31 October 2024

  • Application to amend the Poisons Standard (March 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 March 2025... More
    Closed 8 November 2024

  • Australian Medical Device Essential Principles - Part 2: Proposed alignment with the European Regulation

    UPDATE: Our response to questions asked during the consultation presentation on 11-12 September 2024 has been added to the related documents below the other consultation document links. We have also included a link to the presentation slides. The Therapeutic Goods Administration (TGA) is the Australian government authority responsible for the regulation of therapeutic goods including medicines, medical devices, and biologicals. The Australian (AUS) Essential Principles set out... More
    Closed 13 November 2024

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

    Interim decision This consultation is for an interim decision in relation to nicotinic acid and IV potassium. Once you are familiar with the interim decision, please provide your comments and votes in relation to the interim decision. The closing date for this consultation is close of business 7 January 2024. All submissions received by the deadline will be considered by the delegate before they make an interim decision. The interim decision under consultation are... More
    Closed 7 January 2025

  • Medicine shortages and discontinuations: Proposed changes to reporting requirements

    Medicines are essential for the health and wellbeing of Australians. Medicine shortages can occur for various reasons. Unfortunately, some are unavoidable and can cause significant impact. Through our mandatory reporting scheme, the Therapeutic Goods Administration (TGA) receives and publishes reports of shortages and discontinuations of prescription and certain over-the-counter medicines. We work closely with our stakeholders to respond to shortages and limit their impacts. ... More
    Closed 13 January 2025

  • Review of draft guidance - Complying with the Unique Device Identification regulations for medical devices

    The Therapeutic Goods Administration (TGA) is seeking feedback on a new guidance document being drafted for the Australian UDI system: ‘Complying with the Unique Device Identification regulations for medical devices.’ Please note the following: This document will be published in the TGA's new Guidance format as a web page that can be downloaded or printed as a PDF This document does not contain information about UDI implementation dates as these will be published... More
    Closed 15 January 2025

  • Adoption of International Scientific Guidelines in Australia R01-2024

    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 16 January 2025

  • Review of draft guidance documents - Audit framework for medical devices

    The Therapeutic Goods Administration (TGA) is seeking feedback on two new guidance documents developed as part of the new risk-based application audit framework: 1. Draft Guidance - Selection criteria for non-mandatory application audits. This guidance document outlines and clarifies the selection criteria that influence when we select medical device applications for a non-mandatory application audit, including the rationale for the proposed criteria. 2. Draft... More
    Closed 17 February 2025

  • Public consultation on proposed amendments to the Poisons Standard - ACCS & Joint ACMS-ACCS, MARCH 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 MARCH 2025 meeting of the Advisory Committee on Chemicals Scheduling (ACCS) and the joint meeting of the Advisory Committee on Medicines Scheduling (ACMS) and ACCS. The closing date for this consultation is close of... More
    Closed 17 February 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

  • 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

  • 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
    Opened 12 March 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
    Opened 13 March 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

  • 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 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
    Opened 17 April 2025
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