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137 results

  • 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
    Closed 10 August 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
    Closed 28 July 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
    Closed 14 July 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
    Closed 31 May 2023

  • Hospital and healthcare facility point-of-care manufacturing survey

    Prior to February 2021, most medical devices that were designed and manufactured to suit an individual patient/client were known as “custom-made” medical devices. These kinds of devices were not required to have TGA approval or to be included in the Australian Register of Therapeutic Goods (ARTG) before they could be imported, exported, or supplied (although they were subject to other regulatory obligations). Over the past two decades, rapid advances in computing... More
    Closed 17 May 2023

  • Dental and oral health professionals point-of-care manufacturing survey

    Prior to February 2021, most medical devices that were designed and manufactured to suit an individual patient/client were known as “custom-made” medical devices. These kinds of devices were not required to have TGA approval or to be included in the Australian Register of Therapeutic Goods (ARTG) before they could be imported, exported, or supplied (although they were subject to other regulatory obligations). Over the past two decades, rapid advances in computing... More
    Closed 17 May 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
    Closed 17 May 2023

  • Medical device manufacturing hubs at the point-of-care survey

    Prior to February 2021, most medical devices that were designed and manufactured to suit an individual patient/client were known as “custom-made” medical devices. These kinds of devices were not required to have TGA approval or to be included in the Australian Register of Therapeutic Goods (ARTG) before they could be imported, exported, or supplied (although they were subject to other regulatory obligations). Over the past two decades, rapid advances in computing... More
    Closed 14 May 2023

  • Allied health professionals point-of-care manufacturing survey

    Prior to February 2021, most medical devices that were designed and manufactured to suit an individual patient/client were known as “custom-made” medical devices. These kinds of devices were not required to have TGA approval or to be included in the Australian Register of Therapeutic Goods (ARTG) before they could be imported, exported, or supplied (although they were subject to other regulatory obligations). Medical devices can include assistive technology, whether... More
    Closed 14 May 2023

  • Public Consultation - TGA Fees and Charges proposal 2023-24

    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 2023-24 financial year. Specifically, we are seeking feedback on the potential impact of the proposed fees and charges prior to seeking approval from the Government for any changes. The TGA within the Department of Health and Aged Care is responsible for regulating... More
    Closed 21 March 2023

  • Seeking feedback on improvements to the recalls process

    The Therapeutic Goods Administration (TGA) is seeking feedback on improvements to the therapeutic goods recalls process. In Australia, recalls should be done in accordance with the procedures in our guidance document - the Uniform Recall Procedure for Therapeutic Goods (URPTG) . Performing recalls in accordance with standardised and agreed procedures is important to effectively respond to issues with therapeutic goods which may pose a risk to public health and... More
    Closed 13 March 2023

  • Public consultation on interim decisions to amend the Poisons Standard - ACMS #40 NOVEMBER 2022 (paracetamol)

    Interim decisions regarding substances discussed at the expert advisory meetings. Please note that this consultation is for the interim decision in relation to paracetamol only . If you wish to comment on the interim decisions for other substances discussed at the November 2022 meetings, please see the link below: Consultation for November 2022 (other substances) This consultation is for the interim decision in relation to paracetamol which was discussed at the ... More
    Closed 3 March 2023

  • Public consultation on interim decisions to amend the Poisons Standard - ACMS, ACCS & Joint ACMS-ACCS, NOVEMBER 2022

    Interim decisions regarding substances discussed at the expert advisory meetings. Please note that this consultation is for substances other than paracetamol. If you wish to comment the proposed interim decision in relation to paracetamol please see the link below: Consultation for interim decision for paracetamol This consultation is for interim decisions made in relation to the other substances that were discussed at the November 2022 meetings of the Advisory... More
    Closed 3 March 2023

  • Medicinal Cannabis Program Fees and Charges Review

    On 24 December 2021 several changes to the Narcotic Drugs Act 1967 came into effect, including the introduction of a single licence model for cultivation, production and/or manufacture activities. At this time the Office of Drug Control (ODC) also implemented simpler permit processes and administrative reforms to reduce regulatory burden. Following these reforms, the existing cost model was also reviewed, including the level at which fees and charges are set. In doing so it... More
    Closed 10 February 2023

  • Public consultation on proposed amendments to the Poisons Standard - ACMS, ACCS & Joint ACMS-ACCS, MARCH 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 March 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 3 February 2023. ... More
    Closed 3 February 2023

  • ODC Monitoring and Compliance Section Licence Holder Engagement Survey

    The Office of Drug Control Monitoring and Compliance Section is seeking feedback on its operational performance and engagement with Medicinal Cannabis Licence holders. The medicinal cannabis industry’s feedback will help the Monitoring and Compliance Section meet stakeholders expectations in accordance with best practice regulation. More
    Closed 27 January 2023

  • Proposed reforms to the regulation of nicotine vaping products

    The Therapeutic Goods Administration (TGA) is seeking public comment on potential reforms to the regulation of nicotine vaping products (NVPs) in Australia. The potential reforms are aimed at preventing children and adolescents from accessing NVPs, while supporting access to products of known composition and quality for smoking cessation with a doctor’s prescription. We are seeking public comment on whether you support potential reforms in 4 main areas:... More
    Closed 16 January 2023

  • International harmonisation of ingredient names (IHIN) – Dual labelling transition to sole medicine ingredient names

    The Therapeutic Goods Administration (TGA) is seeking views on medicine ingredient names that must be displayed as both the old and new ingredient name ('dual labelled') on labels and Product Information (PI) and Consumer Medicine Information (CMI) documents until 30 April 2023 as part of International harmonisation of ingredient names (IHIN) . We are seeking feedback on: whether health professionals, consumers and health systems are ready for dual labelling to end... More
    Closed 19 December 2022

  • Online Survey: Consent to import, supply or export a medical device that does not comply with the Essential Principles

    From 1 December 2021, the application for consent to import, supply, or export a medical device that does not comply with the Essential Principles has moved to the TGA Business Services (TBS) portal. The new form will provide stakeholders with a more efficient way of submitting an application to the TGA. The purpose of this survey is to seek your feedback on the new application form. More
    Closed 1 December 2022

  • Public consultation on interim decisions to amend the Poisons Standard - JUNE ACMS INTERIM DECISIONS FOR PSILOCYBINE AND MDMA 2022

    Scheduling amendments referred to expert advisory committee Please note: this is a consultation for the interim decisions relating to PSILOCYBINE and MDMA ONLY. If you wish to provide comments on the other items considered at the ACMS and ACCS meetings in June 2022, please visit the alternate consultation hub by clicking the link below: Consultation for other substances considered in June 2022 This consultation is for interim decisions made in relation to Psilocybine... More
    Closed 24 November 2022

  • Public consultation on interim decisions to amend the Poisons Standard - ACMS/ACCS/Joint ACMS-ACCS JUNE INTERIM DECISIONS 2022

    Scheduling amendments referred to expert advisory committee Please note that there is a separate consultation for interim decisions relating to PSILOCYBINE and MDMA which can be found by clicking the link below: Psilocybine and MDMA consultation 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 June 2022 meetings of the Advisory Committee on... More
    Closed 24 November 2022

  • Boundary and combination products guidance - medicines, medical devices, and biologicals

    The Therapeutic Goods Administration (TGA) is seeking feedback on the draft guidance ‘Boundary and combination products - medicines, medical devices, and biologicals ’ . The purpose of this draft guidance is to assist sponsors and manufacturers in determining the status of therapeutic goods that may not fit clearly within existing definitions for medicines, biologicals, or medical devices. The draft guidance aims to provide clarity on which regulatory pathway is... More
    Closed 20 November 2022

  • Adoption of international scientific guidelines in Australia

    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 10 November 2022

  • Consultation: Regulatory options to allow references to the TGA in therapeutic goods advertising

    The Therapeutic Goods Administration (TGA) is considering regulatory options to allow advertisers, including product sponsors, to make references to the TGA in advertising (including on product labels). We are seeking feedback on: whether references to the TGA should be allowed in therapeutic goods advertising the class or classes of therapeutic goods, if any, that should be allowed to refer to the TGA options for what a reference to the TGA could... More
    Closed 7 November 2022

  • User experience survey - Database of Adverse Event Notifications (DAEN) – medicines beta version

    The Database of Adverse Event Notifications (DAEN) – medicines is the TGA’s public database displaying information about reports of suspected adverse events received in relation to medicines (including vaccines) and biological therapies in Australia. The TGA have created a trial (beta) version of the DAEN – medicines with updated technology to improve its performance, reliability and user experience. The beta version was created to address a decline in the older... More
    Closed 26 October 2022

  • Public consultation on proposed amendments to the Poisons Standard (paracetamol) - ACMS, November 2022

    Potential Scheduling amendments referred to expert advisory committee. Please note that this consultation is for paracetamol only. If you wish to comment on other substances discussed at the November 2022 meetings, please see the link below: Consultation for November 2022 (other substances) This consultation is for possible delegate-initiated proposals to amend the Poisons Standard with regards to paracetamol. The suggested amendments and any... More
    Closed 14 October 2022

  • UDI consultation paper 3: Detailed considerations for implementing the proposed Australian medical device UDI Regulatory Framework

    The Australian Government is undertaking a significant program of reform to the regulation of therapeutic goods in Australia. The reforms will continue 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 and Aged Care, the Therapeutic Goods Administration (TGA) regulates therapeutic goods, and is responsible for implementing the... More
    Closed 11 October 2022

  • Consultation: Product Information as a package insert in boxed injectables

    The Therapeutic Goods Administration (TGA) is requesting feedback on the current usage of the information included with boxed injectables and whether the requirement to include a paper Product Information (PI) as a package insert in boxed injectables is still relevant for those administered by healthcare professionals. In Australia the PI is required to be provided both in the box of injectables and also as an electronic document available on the TGA website. The PI provides... More
    Closed 5 October 2022

  • Public consultation on proposed amendments to the Poisons Standard - ACMS/ACCS/Joint ACMS-ACCS, NOVEMBER 2022

    Scheduling amendments referred to expert advisory committee Please note that this consultation does not include public submissions for paracetamol. To visit the consultation for paracetamol, please see the below link: Paracetamol consultation hub 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 2022 ... More
    Closed 29 September 2022

  • Proposed regulatory changes for clinical trials of medical devices

    The Therapeutic Goods Administration (TGA) is seeking feedback on proposed regulatory changes to strengthen safety oversight of clinical trials for medical devices. The changes are: To increase the degree of regulatory oversight of clinical trials of certain unapproved, high-risk medical devices. To include clinical trials of all medical devices in Australia’s Good Clinical Practice Inspection Program (to enable selected trials and documentation supporting... More
    Closed 28 September 2022
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