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225 results

  • Consultation: Clinical Trials Schemes Improved Information Sharing

    The Therapeutic Goods Administration (TGA) is seeking feedback on new approaches to information sharing under the clinical trial schemes. We propose to strengthen the TGA’s ability to release and publish information relevant to the oversight of clinical trials. These proposals are intended to support regulatory decision-making, collaboration between organisations involved in clinical trials, and transparency of regulatory activities. This consultation seeks your feedback on... More
    Opened 26 October 2026

  • Consultation: Proposed TGA comments to Annex 2 of ICH E6(R3) Guideline for Good Clinical Practice (GCP)

    The Therapeutic Goods Administration (TGA) is seeking feedback on proposed TGA comments to Annex 2 of the ICH E6(R3) Guideline for Good Clinical Practice (ICH GCP E6(R3)). TGA comments explain Australian-specific considerations that should be taken into account when applying the guideline. We are also seeking feedback on the proposal not to provide a transition period for sponsors, trial sites, and other stakeholders, as Annex 2 does not introduce any new requirements, and... More
    Opened 26 October 2026

  • Consultation: Reviewing the exclusion for certain digital mental health tools

    We want your feedback on options for the future regulation of certain digital mental health tools (DMHTs). Digital mental health tools (DMHTs) include apps, websites and chatbots that provide assessment, therapy or self-management strategies for mental health conditions. They are playing an increasingly important role in how Australians access mental health care. Many DMHTs are regulated by the Therapeutic Goods Administration (TGA) as medical devices. However, some... More
    Opened 26 October 2026

  • Additional public consultation on the scheduling of ethylene oxide, propylene oxide and epichlorohydrin

    Proposed scheduling amendments for ethylene oxide, propylene oxide and epichlorohydrin This consultation is in relation to a proposal to amend the current scheduling of ethylene oxide, propylene oxide and epichlorohydrin. All the three substances are listed is the current Poisons Standard as Dangerous Poisons (Schedule 7) without any exception. The applicant proposed that preparations containing less than 0.002% (20 ppm) of ethylene oxide, propylene oxide and... More
    Closed 26 October 2026

  • Public Consultation - TGA fees and charges proposal 2027-28

    Consultation: Fees and Charges Proposal 2027-28 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 2027-28 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
    Opened 19 October 2026

  • High-moderate risk changes to permissible ingredients – Vitamin B6 (pyridoxine hydrochloride, pyridoxal 5-phosphate, and pyridoxal 5-phosphate monohydrate)

    The Therapeutic Goods Administration (TGA) is seeking public comment on proposed changes to the Therapeutic Goods (Permissible Ingredients) Determination (the Permissible Ingredients Determination) relating to listed medicines containing vitamin B6, namely pyridoxine hydrochloride, pyridoxal 5-phosphate, and pyridoxal 5-phosphate monohydrate. Following the scheduling reclassification of pyridoxine, pyridoxal and pyridoxamine (vitamin B6) in the Poisons Standard ,... More
    Opened 14 October 2026

  • Public consultation on proposed amendments to the Poisons Standard in relation to nitrous oxide – Joint ACMS-ACCS #45 – November 2026

    This consultation is for two proposals to amend the current scheduling of nitrous oxide to manage the increasing public health risks from its misuse. The first proposal is initiated by the Delegate and the second proposal has been submitted by a private applicant. Currently, nitrous oxide for therapeutic use is a Prescription only (Schedule 4) substance while for all other uses it a Poison (Schedule 6). Products classified as Schedule 6 are required to carry first aid... More
    Closed 12 October 2026

  • Public consultation on proposed amendments to the Poisons Standard in relation to 4-methylbenzylidene camphor (4-MBC) – Joint ACMS-ACCS #45, November 2026

    This consultation is for a proposal to amend the Poisons Standard in relation to 4-methylbenzylidene camphor (4-MBC). The Delegate and two private applicants have proposed 3 different options to schedule 4-MBC which is not listed in the current Poisons Standard. Option 1 (proposed by the Delegate) This option treats all products consistently and provides one consistent upper limit for 4-MBC for exempting cosmetics and therapeutic sunscreens from the Poisons Standard. ... More
    Closed 12 October 2026

  • Public consultation on proposed amendments to the Poisons Standard – ACCS #43 – NOVEMBER 2026

    Scheduling amendments referred to the Advisory Committee on Chemicals Scheduling This consultation is for Delegate initiated proposals to amend the Poisons Standard. The scheduling amendments and any submissions received will be considered at the November 2026 meeting of the Advisory Committee on Chemicals Scheduling (ACCS) . The closing date for this consultation is close of business 12 OCTOBER 2026. All submissions received by the deadline will be... More
    Closed 12 October 2026

  • Public consultation | Sharing more information about medical devices

    We want your feedback on our proposal to improve sharing information about the safety, quality and performance of medical devices. This will take about 15 minutes to read and complete. The proposed changes intend to provide more information to the public after post-market reviews or investigations of medical devices, particularly where review findings relate to the safety, quality, performance or use of a medical device. These changes align with the intent of An Action Plan... More
    Closed 2 October 2026

  • Proposed changes to support automated decision making (ADM) for applications to change listed medicines

    Proposed changes to support automated decision making (ADM) for applications to change listed medicines Medicines listed in the Australian Register of Therapeutic Goods (ARTG) under section 26A of the Therapeutic Goods Act 1989 (the Act) are included in the ARTG without pre-market assessment by the Therapeutic Goods Administration (TGA). These medicines are self-listed by the applicant (who becomes the sponsor), or an authorised representative on behalf of a sponsor (such as a... More
    Closed 30 September 2026

  • Adoption of International Scientific Guidelines in Australia R01-2026

    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 25 September 2026

  • Proposed changes to Required Advisory Statements for Medicine Labels (RASML)

    The Therapeutic Goods Administration (TGA) is seeking comments from interested parties on proposed changes to the Required Advisory Statements for Medicine Labels (RASML) . RASML sets out advisory statements that are required to be included on the labels of specified OTC and registered complementary medicines. The proposed changes to RASML are: addition of entries for three new substances not currently included in RASML - celecoxib, methenamine and naratriptan ... More
    Closed 4 September 2026

  • Improvements to the Therapeutic Goods Advertising Code

    The Therapeutic Goods Administration (TGA) within the Department of Health, Disability and Ageing is seeking feedback on options and proposed changes to improve the Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021 (the Code). We are reviewing parts of the Code to make sure it: is clear and easy to apply reflects current advertising practices supports safe and appropriate use of therapeutic goods. ... More
    Closed 3 September 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
    Closed 21 August 2026

  • ODC Medicinal Cannabis Permit Holder Supply Pathways 2026

    The Office of Drug Control (ODC) is seeking feedback from permit holders under the Narcotic Drugs Act 1967 on supply pathways used by industry participants. Your feedback will help the ODC better understand current industry practices and identify opportunities to develop practical guidance and support for licence holders. More
    Closed 16 August 2026

  • Proposed changes to the Permissible Indications Determination

    Proposed changes to the Permissible Indications Determination Listed medicines are considered low-risk medicines as they can only use low-risk ingredients and make low-level indications. These medicines are not individually evaluated by the Therapeutic Goods Administration (TGA) before they are released onto the market. Instead, they are automatically included in the Australian Register of Therapeutic Goods (ARTG) following completion of an online application and certification by the... More
    Closed 12 August 2026

  • Digital mental health tools: Service provider survey

    The Therapeutic Goods Administration (TGA) is reviewing the regulations that apply to digital mental health tools (DMHTs). DMHTs are software products including apps, websites, or platforms, that offer assessments, therapy, or self-management strategies to support mental health care. We are seeking information on software and DMHTs in use by digital mental health service providers accredited to the National Safety and Quality Digital Mental Health Standards. A better... More
    Closed 7 August 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
    Closed 31 July 2026

  • Application to amend the Poisons Standard (March 2027)

    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 2027... More
    Opened 17 July 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
    Closed 13 July 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
    Closed 10 July 2026

  • Public consultation on interim decisions to amend the Poisons Standard - ACMS & Joint ACMS-ACCS JUNE, 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 JUNE 2025 meetings of the Advisory Committee on Medicines Scheduling (ACMS) and the ACMS and the Advisory Committee on Chemicals Scheduling (ACCS) in joint session. Kindly note that the interim decisions published below may differ from the initial proposal. Please read through the... More
    Closed 10 July 2026

  • Section 41HD Application Form

    About section 41HD Section 41HD of the Therapeutic Goods Act 1989 (the Act) allows approval to be given for sponsors to supply and/or import medical devices: for a specified timeframe, when there is a disruption or shortage (or will be in the reasonably foreseeable future) of a device included in the Australian Register of Therapeutic Goods (ARTG), and/or it is in the interests of public health (for example,... More
    Opened 2 July 2026

  • Report a potential medical device disruption or shortage

    When to use this form Use this form to report a potential medical device supply disruption or shortage to the Therapeutic Goods Administration (TGA). a shortage of a raw material a shortage of a component a natural disaster/incident interrupts production a manufacturing site issue (e.g. quality control or certification) a transportation/shipping issue or delay an unexpected surge in demand a product is discontinued. Advice about medical... More
    Opened 1 July 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
    Closed 30 June 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

  • 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

  • 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

  • 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
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