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204 results

  • Targeted consultation on proposed changes to the regulation of medicinal maggots

    The Therapeutic Goods Administration (TGA) requests your feedback on proposed regulatory changes to ensure the legislation governing medicinal maggots is fit-for-purpose. Specifically, this consultation seeks feedback on the following proposals: (1) a 2-year transitional licensing exemption from the operation of Part 3-3 of the Therapeutic Goods Act 1989 (the Act) in relation to the manufacture of medicinal maggots (referred to in this paper as the Good Manufacturing... More
    Closed 10 December 2025

  • Public consultation on the interim decision to amend the Poisons Standard in relation to adrenaline - ACMS, June 2025

    Interim decision on proposed amendments to the Poisons Standard in relation to adrenaline. This consultation is for an interim decision made in relation to adrenaline that was discussed at the JUNE 2025 meetings of the Advisory Committee on Medicines Scheduling (ACMS) . Kindly note that the interim decision published below may differ from the initial proposal. Please read through the proposed interim decisions which can be accessed through the links below and are available on... More
    Closed 12 January 2026

  • Public consultation on interim decisions to amend the Poisons Standard - ACCS & Joint ACMS-ACCS - MARCH, 2025

    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 March 2025 meetings of the Advisory Committee on Medicines Scheduling (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 proposed interim decisions which can be... More
    Closed 23 January 2026

  • Public consultation on proposed amendments to the Poisons Standard - ACMS, ACCS & Joint ACMS-ACCS, MARCH 2026

    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 2026 meetings of the Advisory Committee on Medicines Scheduling (ACMS) and the Advisory Committee on Chemicals Scheduling (ACCS) and the Joint meeting of ACMS and ACCS. The closing date for this consultation is... More
    Closed 29 January 2026

  • UDI Consent to Supply approach and fees

    In March 2025 the Therapeutic Goods (Medical Devices) Regulations 2002 were updated to include Unique Device Identification (UDI) requirements. Mandatory compliance is set to begin on 1 July 2026 for Class III and IIb medical devices, followed by lower device classes over later years . Compliance with UDI requirements is a significant undertaking as it impacts manufacturing processes, quality management systems, IT systems and business processes. The... More
    Closed 30 January 2026

  • Adoption of International Scientific Guidelines in Australia R01-2025

    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... More
    Closed 10 February 2026

  • Digital Mental Health Tools User Survey

    The number of people using software, including artificial intelligence (AI), to diagnose, manage and treat mental health conditions is growing. Apps, websites, and computer programs designed for these purposes are referred to as digital mental health tools. The Therapeutic Goods Administration (TGA) is reviewing how these tools are regulated in Australia to make sure these products are safe. More
    Closed 13 February 2026

  • Digital Mental Health Tools Regulatory Environment Survey

    There is growing interest in using software and artificial intelligence (AI) in healthcare delivery, including where it is used to support people with mental health conditions. The Therapeutic Goods Administration (TGA) is reviewing the regulations that apply to software-based medical devices – including digital mental health tools (DMHTs) – that are used to screen, diagnose, monitor and/or treat patients experiencing mental health conditions. We are seeking... More
    Closed 13 February 2026

  • Consultation: Improved sharing of information about medical devices | Proposed amendments relating to transparency of disruptions to supply of a medical device

    We want your feedback on the proposed changes to improve transparency about disruptions to the supply of medical devices. The proposed changes are intended to help in monitoring, assessing and responding to potential and actual supply disruptions. These changes align with the intent of An Action Plan for Medical Devices to provide more information to patients about the medical devices they use. What this consultation is about The consultation... More
    Closed 20 February 2026

  • Public Consultation - TGA fees and charges proposal 2026-27

    Consultation: Fees and Charges Proposal 2026-27 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 2026-27 financial year. Specifically, we are seeking feedback on the potential impact/s of the proposed changes to fees and charges prior to seeking approval from the Government for any changes. The TGA,... More
    Closed 27 February 2026

  • Public Consultation - Annual Charge Exemption (ACE) Scheme Compliance Program Updates

    Annual Charge Exemption Scheme The Annual Charge Exemption (ACE) scheme commenced on 1 July 2015. It provides an exemption from paying Therapeutic Goods Administration (TGA) annual charges until a therapeutic good covered by an entry on the Australian Register of Therapeutic Goods (ARTG) begins generating turnover. The scheme allows sponsors to enter their goods in the ARTG in advance of marketing without incurring an annual charge, until the goods are taken to the market. ... More
    Closed 20 March 2026

  • Form: Intent to submit to AusUDID using M2M HL7 SPL

    This form is for medical device sponsors, manufacturers, agents or third party data providers. It lets you advise the Therapeutic Goods Administration (TGA) that you plan to submit data to the Australian Unique Device Identification Database (AusUDID) using the M2M HL7 SPL submission method. Important information: You cannot submit data to the AusUDID using M2M HL7 SPL until this form is completed. For more information on using the M2M... More
    Opened 23 March 2026

  • Consultation on proposed changes to labelling of medicines supplied in Australia

    Medicine labels give health professionals and consumers important information to help use medicines safely and correctly. If labels are hard to read or understand, medication errors are more likely. Medicines prescribed or given by a health professional have different risks and need different information on the label compared to medicines chosen off the shelf by a consumer. Because of this, there are two labelling standards in Australia that set out what information must... More
    Closed 23 March 2026

  • Increasing transparency of Good Manufacturing Practice (GMP) inspection outcomes

    The Therapeutic Goods Administration (TGA) is seeking feedback on a proposal to publish information about Good Manufacturing Practice (GMP) compliance on the TGA website. The purpose of publishing this information is to: improve transparency of regulatory oversight of the manufacture of pharmaceutical products supplied in Australia; help the public better understand the safeguards in place to ensure quality of pharmaceutical products; and ... More
    Created 31 March 2026

  • Application to amend the Poisons Standard (July 2026)

    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 July 2026... More
    Closed 10 April 2026

  • Consultation: Conformity Assessment Procedures for Medical Devices | Proposed Amendments

    We are aware of recent proposed changes to the European regulations. Those proposed changes will be considered with the responses to this consultation. The TGA has been systematically reviewing the way medical devices are regulated. This has been guided by An Action Plan for Medical Devices which is a three-part strategy to strengthen Australia’s regulatory system while continuing to be patient focused and have greater transparency. The Australian Government is also... More
    Closed 14 April 2026

  • Application to amend the Poisons Standard (NOVEMBER 2026)

    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 17 April 2026

  • Personalised medical devices consumer survey

    The Therapeutic Goods Administration (TGA) regulates medical devices to ensure they are safe and work as intended. We regularly review and update our rules to keep pace with technology and protect patients and consumers. We are currently reviewing personalised medical devices. These are devices designed and made to suit you personally. This is often done by taking a scan or a physical impression of a body part, and making the device based on these. Examples of... More
    Closed 24 April 2026

  • Targeted consultation - AP scheme for psychedelics

    This publication sets out the final recommendations from the targeted consultation and subsequent stakeholder engagements on access to 3, 4-methylenedioxy-methamphetamine (MDMA) and psilocybine under the Authorised Prescriber (AP) scheme. On 1 July 2023, the Poisons Standard was amended to allow access to MDMA for the treatment of post-traumatic stress disorder and psilocybine for treatment-resistant depression by psychiatrists who are specifically authorised under the... More
    Closed 19 May 2026

  • Improvements to the regulation of sunscreens in Australia

    Seeking feedback on improvements to the regulation of sunscreens in Australia Recent international and domestic developments have highlighted a number of matters in relation to the current regulation of sunscreens. Given Australia has the highest rates of skin cancer and melanoma in the world with around 2,000 people dying each year, it is critical that the regulatory settings are appropriate to ensure consumer confidence in sunscreens. The TGA is seeking feedback... More
    Closed 23 May 2026

  • Public consultation on interim decision to amend the Poisons Standard in relation to psilocybine - ACMS JUNE 2025

    Interim decisions regarding substances discussed at the expert advisory meetings. This consultation is for the interim decision made in relation to psilocybine that was discussed at the June 2025 meeting of the Advisory Committee on Medicines Scheduling (ACMS) . Kindly note that the interim decision published below may differ from the initial proposal. Please read through the proposed interim decision which can be accessed through the link below and is available on the... More
    Opened 29 May 2026

  • Public consultation on proposed amendments to the Poisons Standard - ACMS & Joint ACMS-ACCS - JULY 2026

    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 JULY 2026 meetings of the Advisory Committee on Medicines Scheduling (ACMS) and the Joint Meeting of Advisory Committee on Chemicals Scheduling (ACCS) and ACMS. The closing date for this consultation is close of... More
    Opened 29 May 2026

  • Form: Confirmation of M2M HL7 SPL testing completion

    This form is for medical device sponsors, manufacturers, or agents. It lets you advise the Therapeutic Goods Administration (TGA) that you confirm that your organisation has completed M2M HL7 SPL testing in accordance with the validation procedure in the M2M HL7 SPL – User Guide – AusUDID and is ready to submit UDI records to the AusUDID Production environment, using HL7 SPL. In particular, the confirmation is designed to reflect that you have undertaken all necessary... More
    Opened 4 June 2026

  • Radiopharmaceutical regulation in Australia - Open public consultation

    The Therapeutic Goods Administration (TGA) is seeking high‑level stakeholder feedback on how current regulatory settings for radiopharmaceuticals operate in practice. This consultation is intended to support informed consideration of stakeholder experiences with existing regulatory pathways, exemptions and access mechanisms. Feedback received will be used to inform future targeted consultation and engagement activities. To support stakeholder feedback, the TGA has... More
    Opened 5 June 2026
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