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) (74)
- Therapeutic goods regulation (18)
- Over the counter (OTC) medicines (14)
- Prescription medicines (13)
- Legislation (10)
- Complementary medicines (9)
- Advisory bodies and committees (8)
- Listed medicines (8)
- Non-prescription medicines (8)
- Labelling and packaging (6)
- Manufacturing (6)
- Medical devices safety (4)
- Advertising (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)
- Artificial Intelligence (AI) (1)
- Clinical trials (1)
- Disinfectants/Sterilants (1)
- Medicinal cannabis hub (1)
- Shortages (1)
- Unique Device Identification (UDI) hub (1)
- Vaping hub (1)
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242 result(s) found, displaying 1 to 25
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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), 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 feedback on the proposed temporary labelling exemptions for paracetamol.
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Closes 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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Closes 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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Closes 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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Closes onConsultationThe TGA is seeking feedback on proposed changes to the regulation of assistive technologies.
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Closed onConsultationThe TGA is seeking feedback from interested parties on proposed changes to the requirements of ingredients used in listed (low-risk) medicines.
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Closes 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 from interested parties on the proposed changes to replace the sunsetting TGO 70C with a new instrument
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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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Closed onConsultationHave your say on potential reforms to Part 5 of the Therapeutic Goods Regulations 1990.
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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 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 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 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 onConsultationWe are seeking your feedback on the updated draft Companion Diagnostics (CDx) Guidance document.
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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.
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Closed onConsultationThis 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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Closed onConsultationWe 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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Closed onConsultationWe are seeking feedback on whether certain international scientific guidelines should be adopted.
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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 feedback on two new quality standards for MDMA and psilocybin that will be registered as legislative instruments, as Therapeutic Goods Orders (TGOs). This consultation closes on 31 January 2024.
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Closed onConsultationHave your say on proposed amendments to the Poisons Standard, to be considered at advisory committees in November 2023.