The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
Use the filters or search function to help find relevant consultations.
Consultations
Search open and closed consultations on the way we regulate medicines, medical devices and biologicals.
- You can also find, read and respond to recent consultations, submissions and decisions at the TGA Consultation hub.
- Find more scheduling consultations on the Poisons Standard in our Interim decisions.
- Archived consultations and reviews can be viewed on the National Library of Australia Trove site.
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- Scheduling (national classification system) (77)
- Therapeutic goods regulation (18)
- Prescription medicines (15)
- Over the counter (OTC) medicines (14)
- Legislation (12)
- Complementary medicines (11)
- Advisory bodies and committees (10)
- Non-prescription medicines (10)
- Listed medicines (9)
- Labelling and packaging (6)
- Manufacturing (6)
- In Vitro Diagnostic medical devices (IVDs) (4)
- Medical devices safety (4)
- Advertising (3)
- Biological medicines (3)
- Medicine 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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Search
251 result(s) found, displaying 1 to 25
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Closes onConsultationWe are seeking stakeholders’ feedback on proposed changes to the IVD medical device classifications and definitions.
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Closes onConsultationHave 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), or a joint meeting of the ACMS and Advisory Committee on Chemicals Scheduling (ACCS) -
Closed onConsultationWe are seeking feedback on two new guidance documents developed as part of the proposed new risk-based application audit framework.
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Closed onConsultationHave your say about proposals to amend the Poisons Standard. These will be considered at the next meeting of the Advisory Committee on Chemicals Scheduling (ACCS) and joint meeting of the Advisory Committee on Medicines Scheduling (ACMS) and ACCS.
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Closed onConsultationWe are seeking feedback on whether 19 international scientific guidelines should be adopted.
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Closed onConsultationWe are seeking feedback on proposed improvements to TGA’s regulatory framework for medicine shortages and discontinuations in Australia.
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Closed onConsultationHave 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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Closed onConsultationThe TGA is seeking feedback on proposed changes to the regulation of assistive technologies.
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Closed onConsultationHave 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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Closed onConsultationThis consultation paper seeks feedback on proposals identified for mitigating risks and leveraging opportunities associated with the use of AI models.
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Closed onConsultationThis 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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Closed onConsultationWe 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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Closed onConsultationWe are seeking feedback on the proposed temporary labelling exemptions for paracetamol.
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Closed onConsultationThe TGA sought feedback from interested parties on proposed changes to the requirements of ingredients used in listed (low-risk) medicines.
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Closed onConsultationThe 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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Closed onConsultationHave your say on the need for additional clarity and transparency on the regulatory category of some boundary and combination products.
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Closed onConsultationHave your say on potential reforms to Part 5 of the Therapeutic Goods Regulations 1990.
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Closed onConsultationThe 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
Closed onConsultationHave your say on best way to estimate sunscreen use in Australia. Your feedback will be used to calculate the safe concentration of sunscreen ingredients. -
Closed onConsultationHave your say about proposed changes to address 3 medicine safety matters needing action, before we review labelling rules more broadly.
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Closed onConsultationWe are seeking your feedback on the updated draft Companion Diagnostics (CDx) Guidance document.
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Closed onConsultationWe are seeking feedback on proposed changes to the regulation of exempt medical devices and exempt Other Therapeutic Goods (OTGs).
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Closed onConsultationWe 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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Closed onConsultationHave 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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Closed onConsultationWe are seeking your feedback on proposed changes to clarify Clinical Decision Support System (CDSS) software regulation.