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  • Instructions For Use for Medical Devices

    The Therapeutic Goods Administration (TGA) is the Australian government authority responsible for the regulation of therapeutic goods including medicines, medical devices, and biologicals to help Australians stay healthy and safe. The Therapeutic Goods Act 1989 and associated supporting legislation set out the regulatory requirements for medical devices. This includes the information to be provided with a medical device through product label and Instructions for Use (IFU) and the... More
    Opened 15 April 2024

  • Proposed changes to the regulation of exempt medical devices and exempt Other Therapeutic Goods

    The TGA is Australia's government authority responsible for evaluating, assessing and monitoring products that are defined as therapeutic goods. The TGA regulates therapeutic goods including medicines, medical devices and biologicals to help Australians stay healthy and safe. Products that meet the legislative definition of a therapeutic good under the Therapeutic Goods Act 1989 (the Act) are regulated by the TGA and generally need to seek pre-market approval and be included in the ... More
    Opened 15 April 2024

  • Public consultation on interim decisions to amend the Poisons Standard - ACMS, ACCS & Joint ACMS-ACCS NOVEMBER, 2023

    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 2023 meetings of the Advisory Committee on Medicines Scheduling (ACMS) and the Advisory Committee on Chemicals Scheduling (ACCS) . The interim decisions published below may differ from the initial proposal. Please read through the proposed interim decisions which can be accessed through... More
    Opened 3 April 2024

  • Draft guidance: Review of first-in-human high-risk implantable or cardiac invasive medical device clinical trials and Investigator’s brochures for medical device clinical trials

    The Therapeutic Goods Administration (TGA) is seeking feedback on two draft guidance web pages it will publish. The first page explains how the review of Clinical Trial Notifications (CTNs) for first-in-human clinical trials of the highest-risk implantable and cardiac invasive medical devices will operate. The second page describes the general expectations for the contents of an Investigator’s Brochure, which the TGA may review in certain circumstances as part of the process. These... More
    Opened 15 March 2024

  • Companion diagnostics guidance update- public consultation

    The Therapeutic Goods Administration (TGA) is seeking your feedback on the updated draft Companion Diagnostics (CDx) Guidance document. The proposed updates aim to provide sponsors and manufacturers of medicines, biologicals and IVD medical devices further clarification regarding the requirements for companion testing, including: A CDx testing identification guide to assist them in identifying whether their medicine or biological indication requires companion... More
    Opened 15 March 2024

  • Proposed clarification of how Clinical Decision Support System (CDSS) software is regulated

    The Therapeutic Goods Administration (TGA), as part of the Australian Government Department of Health and Aged Care, regulates therapeutic goods including medicines, medical devices, and biologicals to help Australians stay healthy and safe. Ongoing reforms are undertaken by the TGA to ensure the regulatory oversight of all therapeutic goods remains appropriate. The objective of the reforms is to ensure the sustainability of the Australian regulatory system for therapeutic... More
    Opened 12 March 2024

  • Application to amend the Poisons Standard (November 2024)

    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 4 March 2024

  • Public consultation on Camellia sinensis extracts, amygdalin and hydrocyanic acid in the Poisons Standard

    Public consultation on amending the Poisons Standard regarding Camellia sinensis extract, amygdalin and hydrocyanic acid Suggested scheduling amendments for Camellia sinensis extracts, amygdalin and hydrocyanic acid This consultation is in relation to two proposals to: create a new entry for Camellia sinensis (green tea) extract in preparations for internal use, and amend the scheduling for amygdalin and... More
    Opened 1 March 2024

  • [DRAFT] Breast Implant Risk Management Framework

    The Therapeutic Goods Administration (TGA) is seeking comments on a proposed Breast Implant Risk Management Framework. The draft framework describes how the TGA identify, communicate and manage the risks associated with breast implants and what patients can do. More
    Opened 27 February 2024

  • Medicine shortages in Australia – Challenges and opportunities

    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) is responsible for receiving and publishing reports of shortages and discontinuations of prescription and certain over-the-counter medicines. We work closely with our stakeholders to respond to shortages and... More
    Opened 12 February 2024

  • Public Consultation - TGA fees and charges proposal 2024-25

    Consultation: Fees and Charges Proposal 2024-25 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 2024-25 financial year. Specifically, we are seeking feedback on the potential impact/s of the proposed fees and charges prior to seeking approval from the Government for any changes. The TGA, within the... More
    Opened 25 January 2024

  • Adoption of International Scientific Guidelines in Australia R01-2023

    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
    Opened 22 January 2024

  • Pre-meeting public consultation on proposals to amend the Poisons Standard - ACMS, ACCS & Joint ACMS-ACCS, March 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 March 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 5 February 2024. ... More
    Opened 5 January 2024

  • Proposed quality standards for MDMA and psilocybin

    The Therapeutic Goods Administration (TGA) is consulting on two proposed new quality standards for: 3,4‑methylenedioxy‑N-methylamphetamine hydrochloride (MDMA), and psilocybin. The proposed standards include limits on contaminants and synthetic impurities, and accuracy in statement of active ingredients for MDMA and psilocybin. The standards would apply to both compounded and commercially manufactured medicines. ... More
    Opened 8 December 2023

  • Application to amend the Poisons Standard (June 2024)

    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 2024... More
    Opened 8 November 2023

  • Public consultation on interim decisions to amend the Poisons Standard - ACMS, ACCS & Joint ACMS-ACCS JUNE, 2023

    Interim decisions regarding substances discussed at the expert advisory meetings. This consultation is for interim decisions made in relation to the other substances that were discussed at the JUNE 2023 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
    Opened 5 October 2023

  • Public consultation on proposed amendments to the Poisons Standard - ACMS, ACCS & Joint ACMS-ACCS, NOVEMBER 2023

    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 2023 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 29 September... More
    Opened 1 September 2023

  • ODC Monitoring and Compliance Section Cannabis Waste Management Survey

    The Office of Drug Control Monitoring and Compliance Section (MaCS) are seeking clarification of the nature and effectiveness of the various waste management and destruction processes employed by licence holders. This survey will inform ODC decision makers on effective waste management and destruction measures being used. The survey will be used by the ODC to develop guidance and educational materials for industry and enable the ODC to better support licence holders. More
    Opened 25 August 2023

  • MDSAP survey

    The TGA is seeking feedback from Australian Sponsors about the Medical Device Single Audit Program (MDSAP). By completing this survey, your response will help us to better understand any concerns with the operation of the program. Sponsors may reach out to applicable Manufacturers for help answering specific questions on audit activities if necessary, although the intent of the survey is to better understand the Sponsor interactions during MDSAP audits. The following survey should... More
    Opened 25 August 2023

  • Public consultation on interim decision to amend the Poisons Standard - Joint ACMS-ACCS June 2023 - LEAD

    Interim decision regarding lead following the discussions at the Joint meeting of ACMS-ACCS held in June 2023. This consultation is the interim decision for LEAD (in anti-fouling paints) that was discussed at the June 2023 Joint meeting of the Advisory Committee on Medicines Scheduling (ACMS) and the Advisory Committee on Chemicals Scheduling (ACCS) . Kindly note that the interim decision in relation to lead may differ from the initial proposal. Please read through the proposed... More
    Opened 3 August 2023

  • Proposed changes to the Permissible Ingredients Determination: Low-negligible risk changes 2023-24

    The Therapeutic Goods Administration (TGA) is seeking feedback from interested parties on the proposed low-negligible risk changes to the Permissible Ingredients Determination . The proposed changes address the following issues: Curcuma species and curcumin and the risk of liver injury Green tea extract and the risk of liver injury Safe levels of benzophenone Clarification of the requirements for soy phosphatidylserine-enriched... More
    Opened 3 August 2023

  • Public consultation: Proposed application audit framework for medical devices

    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 Government’s reforms. We have issued this consultation paper as part of the reform program. The TGA is responsible for regulating the import, export, and supply of medical devices, including... More
    Opened 26 July 2023

  • Proposed New Guidelines for the Quality of Listed Probiotic Medicines

    The Therapeutic Goods Administration (TGA) is seeking feedback on the proposed new ‘Guidelines for the Quality of Listed Probiotic Medicines (the Guidelines)’. Probiotics are defined as live microorganisms that when administered in adequate amounts, are proposed to confer a health benefit on the host. The quality requirements for listed probiotic medicines are complex to piece together. The purpose of these Guidelines is to help sponsors and manufacturers meet the... More
    Opened 24 July 2023

  • Application to amend the Poisons Standard (March 2024)

    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 2024... More
    Opened 15 July 2023

  • Public consultation on interim decisions to amend the Poisons Standard - ACMS, ACCS & Joint ACMS-ACCS MARCH 2023

    Interim decisions regarding substances discussed at the expert advisory meetings. This consultation is for interim decisions made in relation to the other substances that were discussed at the March 2023 meetings of the Advisory Committee on Medicines Scheduling (ACMS) and 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... More
    Opened 13 July 2023

  • Annual Charge Waiver or Refund for ARTG Entries Subject to Reclassification

    From 1 July 2023, sponsors may apply for an annual charge waiver or refund for eligible transitioning medical devices subject to reclassification. Background In accordance with the Therapeutic Goods Legislation Amendment (2019 Measures No.1) Regulations 2019 , certain categories of medical devices are required to be reclassified so they align, wherever possible with the changes introduced in European Union (EU) medical devices framework. Transitional... More
    Opened 1 July 2023

  • Consultation - Review of regulatory requirements for medical devices containing materials of animal, microbial or recombinant origin

    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 Government’s reforms. We have issued this consultation paper as part of the reform program. The TGA periodically reviews requirements for medical devices to ensure they continue to be... More
    Opened 16 June 2023

  • Application to amend the Poisons Standard

    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. If you are still having difficulties in completing the form, you can contact the Scheduling Secretariat via email. All information provided must be in... More
    Opened 10 May 2023

  • Clarification and updates to the regulation of sunscreens

    The Therapeutic Goods Administration (TGA) is seeking public comment on potential clarification and updates to the regulation of sunscreens. The potential regulatory clarification and updates include: Adoption of the Australian/New Zealand Standard Sunscreen products - Evaluation and classification AS/NZS 2604:2021 Amd 1:2022 (the 2021 Sunscreen Standard) which specifies the current testing and labelling requirements for sunscreens. Removal of the... More
    Opened 24 April 2023

  • Public consultation on proposed amendments to the Poisons Standard - ACMS & Joint ACMS-ACCS, JUNE 2023

    Proposed amendments to the Poisons Standard referred to advisory committees We are consulting on applications and delegate-initiated proposals to amend the Poisons Standard. The proposed amendments and any submissions received will be considered at the June 2023 meetings of the Advisory Committee on Medicines Scheduling (ACMS) and the ACMS and Advisory Committee on Chemicals Scheduling (ACCS) in joint session (Joint ACMS-ACCS). ... More
    Opened 18 April 2023
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