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128 results

  • Public consultation on proposed amendments to the Poisons Standard (oral contraceptives) - ACMS, June 2021

    Scheduling amendments referred to expert advisory committee This consultation is for applications to amend the Poisons Standard in relation to substances used in oral contraceptives. The scheduling proposals, and any submissions received, will be considered at the June 2021 meeting of the Advisory Committee on Medicines Scheduling (ACMS) . The closing date for this consultation is close of business 27 May 2021. All submissions received by the deadline... More
    Closed 27 May 2021
  • SURVEY: Software based Medical Devices – further resources for stakeholders

    From 25 February 2021, a new framework for regulating software as a medical device will commence. The Regulation of software based medical devices details these changes, and additionally the following guidance documents have also been published to assist users understand the various processes relevant to software as a medical device (SaMD): Is my software regulated? How the TGA regulates software based medical devices Regulatory changes... More
    Closed 3 June 2021
  • Public consultation on proposed amendments to the Poisons Standard - ACCS, June 2021

    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 2021 meeting of the Advisory Committee on Chemicals Scheduling (ACCS) . The closing date for this consultation is close of business 4 June 2021. All submissions received by the deadline will be considered by... More
    Closed 4 June 2021
  • Proposed improvements to the Therapeutic Goods Advertising Code

    The Therapeutic Goods Administration (TGA) is seeking feedback on options to improve the Therapeutic Goods Advertising Code (No.2) 2018 (the Code). The Code is the compliance standard that prescribes the minimum requirements for the lawful advertising of therapeutic goods to the general public in Australia. The proposed improvements are aimed at increasing advertisers’ understanding of the requirements of the Code, ensuring provisions work as intended, and... More
    Closed 18 June 2021
  • Remaking of standards and legislative instruments for human cell and tissue products, blood and blood components

    The Therapeutic Goods Administration (TGA) is seeking feedback on a proposal to remake some of the legislative instruments relating to human cell and tissue (HCT) products (including blood and blood components), which sunset in October 2021. We are seeking feedback to make sure the proposed changes: improve clarity on technical requirements ensure alignment with international best practice and standards bring legislation into alignment with... More
    Closed 11 July 2021
  • Proposed refinements to the regulation of personalised medical devices

    On 25 February 2021, changes to the Therapeutic Goods (Medical Devices) Regulations 2002 (‘the Regulations’) commenced to introduce a new regulatory framework (the Framework) for medical devices that are designed and manufactured for individual patients (otherwise known as 'personalised' medical devices). The key change introduced under the Framework is a change to the definition of a custom-made medical device. Custom-made medical devices are exempt products. In Australia, all... More
    Closed 21 July 2021
  • Proposed refinements to the Regulation of medical devices that are substances introduced into the human body via a body orifice or applied to the skin

    In early 2019 the Therapeutic Goods Administration (TGA) conducted a public consultation seeking feedback on a proposal to introduce new classification rules for medical devices composed of substances that are intended to be introduced into the human body through a body orifice, or applied to skin, that are absorbed or dispersed. The proposed regulatory changes supported the commitment made to align Australian medical device regulations, where possible and appropriate, with the European... More
    Closed 13 August 2021
  • Public consultation on interim decisions to amend the Poisons Standard - ACMS/ACCS meetings, March 2021

    Scheduling amendments referred to expert advisory committee This consultation is for interim decisions made in relation to applications and delegate initiated proposals to amend the Poisons Standard, following advice sought at the 17-18 March 2021 meetings of the Advisory Committee on Medicines Scheduling (ACMS) and Advisory Committee on Chemicals Scheduling (ACCS) . The closing date for this consultation is close of business 17 August 2021 . All submissions received... More
    Closed 17 August 2021
  • Australian Register of Therapeutic Goods (ARTG) Search - Feedback Survey

    As part of the TGA Digital Transformation, the public search of the Australian Register of Therapeutic Goods (ARTG) is under review so we can better meet your needs. The ARTG is a register of therapeutic goods that can be lawfully supplied in Australia. We welcome your feedback on the current public ARTG Search on the TGA website More
    Closed 20 August 2021
  • NOTIFICATION FORM: Transition arrangements for software-based medical devices

    Please note this form closes at 11.59pm on 24 August 2021 This form should be used by sponsors and manufacturers of software-based medical devices that will need to be included in the ARTG at a higher classification as a result of the amendments to the Therapeutic Goods (Medical Devices) Regulations 2002 from 25 February 2021. Devices are eligible for transition if: They are software-based medical devices intended for: diagnosing and screening for a disease or condition;... More
    Closed 24 August 2021
  • SURVEY: Personalised medical devices - further resources for stakeholders

    From 25 February 2021, a new framework for regulating personalised medical devices will commence. Comprehensive guidance about the framework can be found at: https://www.tga.gov.au/resource/personalised-medical-devices-including-3d-printed-devices The Therapeutic Goods Administration (TGA) is conducting an education campaign to help stakeholders to understand the new framework and meet their regulatory obligations, ensuring minimal interruption to the supply of personalised... More
    Closed 25 August 2021
  • NOTIFICATION FORM: Transition arrangements for medical devices that record patient images, and anatomical models

    This form should be used by manufacturers and sponsors of medical devices that record patient images or that are anatomical models, and that will be reclassified by the amendments to the Therapeutic Goods (Medical Devices) Regulations 2002 from 25 February 2021. Devices are eligible for transition if: they are medical devices intended to record patient images that are acquired using a method that relies on energy outside the visible spectrum; or they... More
    Closed 25 August 2021
  • Public consultation on interim decisions to amend the Poisons Standard (nitrous oxide) - Joint ACMS-ACCS, March 2021

    Scheduling amendments referred to expert advisory committee This consultation is for an interim decision made in relation to an application to amend the Poisons Standard, following advice sought at the 17-18 March 2021 meetings of the Advisory Committee on Medicines Scheduling (ACMS) and the Advisory Committee on Chemicals Scheduling (ACCS) in joint session. The closing date for this consultation is close of business 27 August 2021 . All submissions received by the... More
    Closed 27 August 2021
  • Proposed refinements to the requirements for medical device patient information materials

    It is important that patients have access to information about their implanted medical devices. Globally, the requirements for medical device patient information materials vary. Implementation of requirements for these materials in Europe is occurring now through to 2024, whilst in USA and Canada there are requirements already in force. In Australia, in late 2017, the Government approved regulations that require patient information materials to be supplied with... More
    Closed 1 September 2021
  • Proposed changes to Required Advisory Statements for Medicine Labels (RASML): Triptans

    The Therapeutic Goods Administration (TGA) is seeking comments from interested parties on proposed new advisory statements for labels of over the counter (OTC) medicines containing triptans (sumatriptan, zolmitriptan, rizatriptan, eletriptan) , for inclusion in the Required Advisory Statements for Medicine Labels (RASML) . The proposal to include advisory statements for triptan-containing medicines in RASML follows recent down-scheduling of triptans when supplied... More
    Closed 17 September 2021
  • Proposed changes to Required Advisory Statements for Medicine Labels (RASML): Mometasone

    The Therapeutic Goods Administration (TGA) is seeking comments from interested parties on proposed advisory statements for labels of over the counter (OTC) medicines containing mometasone in dermal and nasal spray preparations , for inclusion in the Required Advisory Statements for Medicine Labels (RASML) . The proposal to include advisory statements for mometasone-containing medicines in RASML follows recent down-scheduling of mometasone for dermal use when supplied... More
    Closed 17 September 2021
  • Proposed changes to Required Advisory Statements for Medicine Labels (RASML): Melatonin

    The Therapeutic Goods Administration (TGA) is seeking comments from interested parties on proposed advisory statements for labels of over the counter (OTC) medicines containing melatonin, for inclusion in the Required Advisory Statements for Medicine Labels (RASML) . The proposal to include advisory statements for melatonin-containing medicines in RASML follows recent down-scheduling of melatonin when supplied under specific conditions, from Schedule 4 to Schedule 3 of the Poisons... More
    Closed 17 September 2021
  • Proposed minor changes to Required Advisory Statements for Medicine Labels (RASML): Chlorhexidine, hydrocortisone, ibuprofen

    The Therapeutic Goods Administration (TGA) is seeking comments from interested parties on proposed minor changes to advisory statement requirements for labels of over the counter (OTC) medicines containing chlorhexidine, hydrocortisone or ibuprofen , for inclusion in the Required Advisory Statements for Medicine Labels (RASML) . The proposed changes involve minor changes to existing RASML entries to correct or clarify intended requirements and in most cases should... More
    Closed 17 September 2021
  • Proposed changes to the Permissible Ingredients Determination: Low-negligible risk changes 2021-22

    ATTENTION: Due to difficulties many of our stakeholders are experiencing in lockdown, the closing date for submissions to this consultation has been extended until Wednesday 29th September 2021 . The outcomes of the consultation will now be anticipated for publication on Wednesday 15th December 2021 . The Therapeutic Goods Administration (TGA) is seeking feedback from interested parties on the proposed low-negligible risk changes to the Permissible Ingredients... More
    Closed 29 September 2021
  • Public consultation on proposed amendments to the Poisons Standard - ACMS, ACCS and Joint ACMS-ACCS, November 2021

    Scheduling amendments referred to expert advisory committee This pre-meeting 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 2021 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 7... More
    Closed 7 October 2021
  • Public consultation on interim decisions to amend the Poisons Standard - ACMS, June 2021

    Scheduling amendments referred to expert advisory committee This consultation is for interim decisions made in relation to applications and delegate initiated proposals to amend the Poisons Standard, following advice sought at the 23-24 June 2021 meeting of the Advisory Committee on Medicines Scheduling (ACMS) . The closing date for this consultation is close of business 1 November 2021 . All submissions received by the deadline will be considered by the delegate... More
    Closed 1 November 2021
  • Public consultation on interim decisions to amend the Poisons Standard (oral contraceptives) - ACMS, June 2021

    Scheduling amendments referred to expert advisory committee This consultation is for interim decisions made in relation to applications and delegate initiated proposals to amend the Poisons Standard, following advice sought at the 23-24 June 2021 meeting of the Advisory Committee on Medicines Scheduling (ACMS) . The closing date for this consultation is close of business 1 November 2021 . All submissions received by the deadline will be considered by the delegate... More
    Closed 1 November 2021
  • Consultation on Draft Guidance: Assistive Technologies and the Therapeutic Goods (Excluded Goods) Determination 2021

    We have extended the timeframe for submissions to this consultation. We will commence analysing submissions from 22 October 2021. However some stakeholders have requested more time to submit their comments, so the capacity to make submissions will remain open until Friday 5 November 2021. We welcome any feedback stakeholders can provide on this issue. Stakeholders can also provide feedback by email to LowRiskDevices@health.gov.au ________ The Therapeutic Goods... More
    Closed 5 November 2021
  • Public consultation on interim decisions to amend the Poisons Standard - ACCS, June 2021

    Scheduling amendments referred to expert advisory committee This consultation is for interim decisions made in relation to applications and delegate initiated proposals to amend the Poisons Standard, following advice sought at the 22 June 2021 meeting of the Advisory Committee on Chemicals Scheduling (ACCS) . The closing date for this consultation is close of business 11 November 2021 . All submissions received by the deadline will be considered by the delegate before... More
    Closed 11 November 2021
  • Public consultation on interim decisions to amend the Poisons Standard - Joint ACMS-ACCS, June 2021

    Scheduling amendments referred to expert advisory committee This consultation is for interim decisions made in relation to applications and delegate initiated proposals to amend the Poisons Standard, following advice sought at the 23 June 2021 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 11 November 2021 . All submissions... More
    Closed 11 November 2021
  • Public consultation on interim decisions to amend the Poisons Standard (sodium nitrite) - Joint ACMS-ACCS, June 2021

    Scheduling amendments referred to expert advisory committee This consultation is for interim decisions made in relation to applications and delegate initiated proposals to amend the Poisons Standard, following advice sought at the 23 June 2021 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 11 November 2021 . All submissions... More
    Closed 11 November 2021
  • Application for consent to import, supply or export a medical device that does not comply with the Essential Principles

    This form is no longer in use. Please refer to the TGA website to complete an application for consent to import, supply, or export a medical device that does not comply with the Essential Principles. There are Criminal Offences under S41MA and Civil Penalties under S41MAA of the Therapeutic Goods Act 1989 , for persons who import, supply or export medical devices that do not meet the Essential Principles for safety and performance, unless consent has been granted by the Secretary... More
    Closed 30 November 2021
  • Application for consent to import, supply or export a medical device that does not comply with the Essential Principles: Non-compliant Patient Information Materials

    This form is no longer in use. Please refer to the TGA website to complete an application for consent to import, supply, or export a medical device that does not comply with the Essential Principles. There are Criminal Offences under S41MA and Civil Penalties under S41MAA of the Therapeutic Goods Act 1989 , for persons who import, supply or export medical devices that do not meet the Essential Principles for safety and performance, unless consent has been granted by... More
    Closed 30 November 2021
  • Potential for Mandatory Reporting of Medical Device Adverse Events by Healthcare Facilities in Australia

    The Australian Government is undertaking a significant program of reform to improve the safety, performance, and quality of medical devices in Australia and improve health outcomes for patients who require medical devices. As part of the Australian Government Department of Health, the Therapeutic Goods Administration (TGA) regulates medical devices, and is responsible for implementing the Government’s reforms. We released this Discussion Paper seeking feedback on potential changes to... More
    Closed 13 December 2021
  • Potential regulatory options for ‘export only’ biologicals

    The Therapeutic Goods Administration (TGA) is seeking feedback on potential options for the regulation of biological therapeutic goods (biologicals) manufactured in Australia for export only (and not for supply in Australia). Biologicals are human tissue and cell-derived products and live animal cell, tissues or organs. Currently, biologicals included in the Australian Register of Therapeutic Goods (ARTG) can be exported but they are not permitted to vary from the... More
    Closed 22 December 2021
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