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  • Mitochondrial Donation in Australia

    The Australian Government Department of Health invites you to share your views on the proposed approach to making mitochondrial donation available in Australia. The Australian Government wants to introduce mitochondrial donation so this lifesaving technology is made available for families impacted... More
    Closed 15 March 2021
  • Public consultation on interim decisions to amend the Poisons Standard - November 2020 ACMS/ACCS meetings

    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 4-5 November 2020 meetings of the Advisory Committee on... More
    Closed 4 March 2021
  • Removing redundant processes for entering certain formulation information into a therapeutic goods application

    The Therapeutic Goods Administration (TGA) is seeking feedback on a proposal to streamline how information about certain therapeutic goods formulations is entered into TGA electronic systems when seeking market approval. Specifically, we propose to discontinue entering certain types... More
    Closed 24 February 2021
  • Request for Revalidated Service

    This form is to completed if you wish to complete a request for a revalidated service for a client with the Australian Government Hearing Services Program. Please click the link below to begin your request. DISCLAIMER This is a draft form for testing purposes only. The form... More
    Opened 19 February 2021
  • Consultation Paper: Options for Reforms and Improvements to the Prostheses List

    The Department of Health invites submissions in relation to options for reforms and improvements to the Prostheses List. In 2017, the Australian Government entered into the Strategic Agreement with the Medical Technology Association of Australia (MTAA). Through the MTAA Agreement, a... More
    Closed 15 February 2021
  • Productivity Commission Report on Mental Health

    The Australian Government welcomes the Productivity Commission (PC) Inquiry Report on Mental Health. It provides 21 recommendations with 103 associated actions spanning five key themes: prevention and early help for people; improve people’s experiences with mental... More
    Closed 10 February 2021
  • Consultation on the definition of Central Circulatory System (CCS) in the Australian Medical Device Regulations

    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... More
    Closed 10 February 2021
  • Consultation paper: Private health insurance reforms – second wave - December 2020

    On 6 October 2020, the Australian Government announced the second wave of reforms to private health insurance with the aim of improving the affordability, value, and attractiveness of private health insurance, particularly for younger Australians [Budget Paper No.2 - Budget Measure: Supporting... More
    Closed 8 February 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... More
    Opened 5 February 2021
  • NOTIFICATION FORM: Transition arrangements for software-based medical devices

    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... More
    Opened 4 February 2021
  • Hearing Services Program Changes - Questions

    The Department of Health administers the Australian Government Hearing Services Program (the program). The program supports the delivery of hearing services to over one million eligible clients through Contracted Service Providers. More
    Opened 1 February 2021
  • Voluntary Indigenous Identifier Framework

    Since 2002, Aboriginal and Torres Strait Islander people have been able to have their status recorded confidentially on a database called the Voluntary Indigenous Identifier (VII). The VII is primarily used to estimate use of the Medicare Benefits Scheme by Aboriginal and Torres Strait... More
    Closed 31 January 2021
  • Potential reforms to medicinal cannabis manufacturing, labelling and packaging requirements

    The Department of Health through the Therapeutic Goods Administration (TGA) is seeking comments from interested parties on a review of the regulatory processes for the manufacturing, labelling and packaging of medicinal cannabis products. The Therapeutic Goods Administration (TGA) is... More
    Closed 29 January 2021
  • Public consultation on proposed amendments to the Poisons Standard - March 2021 ACMS/ACCS meetings

    Scheduling amendments referred to expert advisory committee This pre-meeting consultation is for applications and delegate initiated proposals to amend the scheduling in the Poisons Standard for certain substances. The scheduling amendments and any submissions received will be... More
    Closed 27 January 2021
  • Aspirations for the food regulatory system

    Reform of the food regulatory system In March 2020, the Australian New Zealand Ministerial Forum on Food Regulation (the Forum) endorsed an implementation plan for an ambitious reform agenda for the food regulatory system aimed at ensuring the system remains strong, robust and agile into... More
    Closed 22 January 2021
  • Review of the National Bowel Cancer Screening Program - Have Your Say

    We are seeking your views on the Australian Government’s National Bowel Cancer Screening Program (the Program). The Department of Health has commissioned an independent and comprehensive review of the Program. The Review will measure the extent to which the program is meeting its... More
    Closed 8 January 2021
  • Community Visitors Scheme - Performance Reporting

    Survey - CVS Performance Reporting More
    Closed 8 January 2021
  • NOTIFICATION FORM: Clinical decision support software exemption

    This notification form is for Australian manufacturers or sponsors of clinical decision support software, that meet the exemption criteria outlined in the Therapeutic Goods (Medical Devices) Regulations 2002 . The exemption applies to medical devices that are clinical... More
    Opened 4 January 2021
  • Exploring options for the introduction of an Australian Unique Device Identification (UDI) System: UDI consultation paper 2

    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... More
    Closed 24 December 2020
  • Medicinal Cannabis Permit Reform

    The Department of Health through the Office of Drug Control (ODC) is seeking comments from interested parties on a review of the structure, design and administrative processes for medicinal cannabis related permits (the review). This review is part of the broader reforms being... More
    Closed 18 December 2020
  • Consistency of food regulatory approaches

    In March 2020, the Australian New Zealand Forum on Food Regulation (the Forum) endorsed an implementation plan for an ambitious reform agenda for the food regulatory system aimed at ensuring the system remains strong, robust and agile into the future. The reform agenda is being progressed through... More
    Closed 18 December 2020
  • Compounded medicines and good manufacturing practice (GMP)

    The current guidance Compounded medicines and good manufacturing practice (GMP) was developed in relation to the PIC/S Guide to GMP for Medicinal Products PE-009-8 15 January 2009, following public consultation in 2015. This document provides guidance on the interpretation of the PIC/S Guide to... More
    Closed 18 December 2020
  • 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... More
    Opened 14 December 2020
  • Hearing Services Program Review - Consultation Paper

    On 14 August 2020, the Hon Mark Coulton, Minister for Regional Health, Regional Communications and Local Government, announced a review into the Hearing Services Program. An Independent Panel made up of Professor Mike Woods (Chair) and Dr Zena Burgess will conduct the Review, with the... More
    Closed 4 December 2020
  • National Suicide Prevention Taskforce – Interim Advice Public Consultation

    The Australian Government is working towards zero suicides and appointed Ms Christine Morgan as the first National Suicide Prevention Adviser reporting directly to the Prime Minister. The National Suicide Prevention Adviser has provided the Prime Minister with the... More
    Closed 3 December 2020
  • National Pancreatic Cancer Roadmap

    Cancer Australia has invited the public to have their say on the National Pancreatic Cancer Roadmap through this dedicated Consultation Hub. The National Pancreatic Cancer Roadmap Consultation Hub is now closed. Cancer Australia thanks all those who contributed to the Roadmap through the... More
    Closed 30 November 2020
  • Proposed changes to the recommended use of the rabies vaccine

    The Australian Technical Advisory Group on Immunisation (ATAGI) is consulting with stakeholders on proposed changes to rabies vaccination recommendations for inclusion in the Australian Immunisation Handbook, with an intention to submit the recommendation to the National Health and Medical... More
    Closed 18 November 2020
  • Proposed amendment to the Australian Immunisation Register Act 2015

    Changes to the Australian Immunisation Register legislation We're seeking feedback on proposed changes to the Australian Immunisation Register Act 2015 (AIR Act). The proposed amendment to the AIR Act is to make it mandatory for all recognised vaccination... More
    Closed 15 November 2020
  • Notice of an interim decision to amend the current Poisons Standard in relation to nicotine - Joint ACMS-ACCS meeting, June 2020

    Interim decision to amend the current Poisons Standard in relation to nicotine, Joint ACMS-ACCS meeting #25, June 2020 This consultation is for an interim decision to amend the scheduling of nicotine in the current Poisons Standard, following advice sought at the 23 June 2020 meeting of... More
    Closed 12 November 2020
  • Second phase open consultation for the National Dust Disease Taskforce

    Background In January 2020, the Minister for Health, the Hon Greg Hunt MP, released the Interim Advice from the National Dust Disease Taskforce. A copy of the Interim Advice and Minister’s media release can be found under Related Documents. Why we are... More
    Closed 11 November 2020
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