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)
- Vaping hub (1)
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251 result(s) found, displaying 151 to 175
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Closed onConsultationThis consultation considers the EU regulatory framework as an input into the review and reform of the Australian regulatory requirements for medical devices classification. Closing date: 29 April 2019
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Closed onConsultationThis consultation paper considers the EU regulatory framework as an input into the review and reform of the Australian regulatory requirements for medical devices classification. Closing date: 29 April 2019
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Closed onConsultationThrough a targeted consultation, the TGA invited views of a number of stakeholders on proposed options for process improvements
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Closed onConsultationThe TGA sought comments from interested parties on the proposed criteria, accompanying guidance and plans for monitoring of the supply of Schedule 3 (S3) Pharmacist only - Appendix M substances. Closing date: 1 April 2019
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Closed onConsultationThe TGA sought feedback on how personalised medical devices are regulated in Australia. Closing date: 31 March 2019
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Closed onConsultationThis consultation paper considers the EU regulatory framework as an input into the review and reform of the Australian regulatory requirements for medical devices classification. Closing date: 31 March 2019
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Closed onConsultationThe TGA sought feedback on how software, including Software as a Medical Device, is regulated in Australia. Closing date: 31 March 2019
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Closed onConsultationThe TGA is seeking comments from interested parties on Options for the Regulation of Faecal Microbiota Transplantation materials.
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Closed onConsultationWe seek your views on the proposed regulatory changes that would facilitate the adoption of the internationally harmonised principles for introduction of the UDI system in Australia. Closing date: 18 February 2019
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Consultation: Potential reclassification of active medical devices for diagnosis and patient therapy
Closed onConsultationThe TGA seeks comments on the extent to which a similar approach will be appropriate in the Australian regulatory context. Closing date: 18 February 2019 -
Closed onConsultationThe TGA sought comments on the proposal to introduce new and amended definitions, and a revised scope of the products regulated as medical devices in Australia. Closing date: 18 February 2019
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Closed onConsultationThe TGA sought comments on the applicability and usefulness of the content contained in the draft regulatory guidance and information materials. Closing date: 14 February 2019
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Closed onConsultationInvitation to comment on proposed amendments to the Poisons Standard - ACCS, March 2019 (late addition to the published agenda). Closing date: 8 February 2019
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Closed onConsultationProposed Amendments to the Poisons Standard are now available for public comment. Closing date: 21 January 2019
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Closed onConsultationDiscussion paper outlining different approaches to access and safety controls for alkyl nitrites
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Closed onConsultationClosing date extended to 14 December 2018
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Closed onConsultationAdvisory Committee on Medicines Scheduling to consider upscheduling of modified release paracetamol to 'Pharmacist Only'. Closing date 31 October 2018
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Closed onConsultationThe IMDRF sought comments on a proposed guidance document and two information documents
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Closed onConsultationThe IMDRF sought comments on a proposed document and its annexes
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Closed onConsultationInvitation to comment on proposed Poisons Standard amendments. Closing date: 28 September 2018
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Closed onConsultationThe IMDRF is seeking comments on a proposed guidance document
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Closed onConsultationThe TGA is seeking comments on the proposed guidance for the use of Boxed Warnings for prescription medicines. Closing date: 31 August 2018
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Closed onConsultationThe TGA sought comments on the proposed Schedule 3 substances to be added to Appendix H of the Poisons Standard to allow them to be advertised direct to consumers. Closing date 9 July 2018
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Closed onConsultationCarbendazim has been deferred from the June 2018 ACCS meeting at the applicant’s request.
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Closed onConsultationConsultation on options for a regulatory response to the potential misuse of prescribed Schedule 8 opioids in Australia