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  • 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
  • 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
    Opened 25 March 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
    Opened 25 March 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
    Opened 25 March 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
    Opened 25 March 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
    Opened 21 February 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
    Opened 3 February 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
    Opened 3 February 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
    Opened 30 January 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
    Opened 5 January 2023
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