Find activities

224 results

  • 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
    Opened 15 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

  • 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
    Opened 27 July 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
    Opened 31 July 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
    Opened 13 August 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
    Opened 17 August 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
    Opened 18 August 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
    Opened 11 September 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
    Opened 11 September 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
    Opened 11 September 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 - 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

  • 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
    Opens 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
    Opens 26 October 2026
224 results. Page 8 of 8