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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Topic
- Scheduling (national classification system) (81)
- Legislation (15)
- Committees and advisory bodies (12)
- Labelling and packaging (7)
- Manufacturing (7)
- Safety monitoring and information (5)
- Advertising (3)
- Fees and payments (3)
- Import and export (3)
- Sunscreens (3)
- Medicinal cannabis hub (2)
- Shortages and supply disruptions (2)
- Clinical trials (1)
- Compliance and enforcement (1)
- Unique Device Identification (UDI) hub (1)
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266 result(s) found, displaying 26 to 50
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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ConsultationWe are seeking feedback on draft guidance documentation 'Regulatory changes for medical devices containing medicinal substances or materials of animal, microbial, or recombinant origin - guidance on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 the need for additional clarity and transparency on the regulatory category of some boundary and combination products.
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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 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.
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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 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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ConsultationHave your say on proposed amendments to the Poisons Standard, to be considered at advisory committees in November 2023.
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ConsultationWe conducted a public consultation to seek feedback from interested parties on proposed changes to the requirements of ingredients used in listed (low-risk) medicines.
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ConsultationWe sought feedback on the proposed new ‘Guidelines for the Quality of Listed Probiotic Medicines’.
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ConsultationThe TGA is sought feedback on how we select medical device applications for audit and how we conduct these audits.
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ConsultationThe TGA periodically reviews requirements for medical devices to ensure they continue to be appropriate. Closing 28 July 2023.