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Consultations
We consult on proposed changes to the way we regulate medicines, medical devices and biologicals. Additional consultations about changes to the Poisons Standard can be found in the Scheduling decisions (interim) section of our publications hub.
See all open and recent consultations, submissions and decisions at the TGA Consultation hub.
More on consultations
Find more scheduling consultations on the Poisons Standard in our Interim decisions.
Trove at the National Library of Australia has information on archived TGA consultations and reviews.
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Topic
- Scheduling (national classification system) (75)
- Therapeutic goods regulation (18)
- Prescription medicines (15)
- Over the counter (OTC) medicines (14)
- Legislation (12)
- Complementary medicines (11)
- Listed medicines (10)
- Non-prescription medicines (10)
- Advisory bodies and committees (8)
- Labelling and packaging (6)
- Manufacturing (6)
- Medical devices safety (4)
- Advertising (3)
- Biological medicines (3)
- In Vitro Diagnostic medical devices (IVDs) (3)
- Medicines safety (3)
- Sunscreens (3)
- Australian Register of Therapeutic Goods (ARTG) (2)
- Fees and payments (2)
- Import and export (2)
- Safety (2)
- Shortages (2)
- Artificial Intelligence (AI) (1)
- Assessed listed medicines (1)
- Blood and blood components (1)
- Clinical trials (1)
- Disinfectants/Sterilants (1)
- Medicinal cannabis hub (1)
- Registered complementary medicines (1)
- Unique Device Identification (UDI) hub (1)
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248 result(s) found, displaying 1 to 25
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ConsultationWe are seeking feedback on proposed improvements to TGA’s regulatory framework for medicine shortages and discontinuations in Australia.
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ConsultationWe are seeking feedback on whether 19 international scientific guidelines should be adopted.
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ConsultationHave your say on the proposed changes to the Australian Essential Principles for Safety and Performance of medical devices (Essential Principles). Closing date has been extended from 16 October to 13 November 2024.
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ConsultationWe are seeking feedback on two new guidance documents developed as part of the proposed new risk-based application audit framework
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ConsultationThe TGA is seeking feedback on proposed changes to the regulation of assistive technologies.
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ConsultationHave your say about proposals to amend the Poisons Standard. These will be considered at the next meeting of the Advisory Committee on Medicines Scheduling (ACMS), meeting of the Advisory Committee on Chemicals Scheduling (ACCS), or a joint meeting of these two committees.
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ConsultationThis consultation paper seeks feedback on proposals identified for mitigating risks and leveraging opportunities associated with the use of AI models.
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ConsultationThis consultation is for interim decisions made in relation to substances that were discussed at the JUNE 2024 meetings of the Advisory Committee on Medicines Scheduling (ACMS) and the Advisory Committee on Chemicals Scheduling (ACCS).
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ConsultationWe are seeking feedback on draft guidance documentation 'Regulatory changes for medical devices containing medicinal substances or materials of animal, microbial, or recombinant origin - guidance on the new regulatory requirements and transition arrangements'.
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ConsultationWe are seeking feedback on the proposed temporary labelling exemptions for paracetamol.
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ConsultationThe TGA sought feedback from interested parties on proposed changes to the requirements of ingredients used in listed (low-risk) medicines.
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ConsultationThe TGA is seeking feedback from interested parties on the proposed changes to replace the sunsetting TGO 70C with a new instrument
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ConsultationHave your say on potential reforms to Part 5 of the Therapeutic Goods Regulations 1990.
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ConsultationThe TGA is seeking feedback on a revised version of the guidance document ‘TGA Instructions for Disinfectant Testing’.
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Consultation: Proposed exposure model for assessing the safety of sunscreen ingredients in Australia
ConsultationHave your say on best way to estimate sunscreen use in Australia. Your feedback will be used to calculate the safe concentration of sunscreen ingredients. -
ConsultationHave your say on the need for additional clarity and transparency on the regulatory category of some boundary and combination products.
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ConsultationHave your say about proposed changes to address 3 medicine safety matters needing action, before we review labelling rules more broadly.
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ConsultationWe are seeking your feedback on the updated draft Companion Diagnostics (CDx) Guidance document.
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ConsultationWe are seeking feedback on proposed changes to the regulation of exempt medical devices and exempt Other Therapeutic Goods (OTGs).
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ConsultationWe sought feedback on how Instructions for Use (IFU) are provided, and whether IFUs should be made available in more flexible formats.
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ConsultationHave your say about proposals to amend the Poisons Standard. These will be considered at the next meeting of the Advisory Committee on Medicines Scheduling (ACMS), meeting of the Advisory Committee on Chemicals Scheduling (ACCS), or a joint meeting of these two committees.
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ConsultationWe are seeking your feedback on proposed changes to clarify Clinical Decision Support System (CDSS) software regulation.
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ConsultationThis consultation is for interim decisions made in relation to substances that were discussed at the NOVEMBER 2023 meetings of the Advisory Committee on Medicines Scheduling (ACMS) and the Advisory Committee on Chemicals Scheduling (ACCS)
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ConsultationWe are consulting to better understand the nature, extent and urgency of problems with the supply of medicines, including shortages and discontinuations of medicines in Australia.
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ConsultationWe are seeking feedback on whether certain international scientific guidelines should be adopted.