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) (83)
- Legislation (16)
- Committees and advisory bodies (12)
- Labelling and packaging (9)
- Manufacturing (9)
- Safety monitoring and information (6)
- Fees and payments (5)
- Advertising (4)
- Sunscreens (4)
- Import and export (3)
- Shortages and supply disruptions (3)
- Compliance and enforcement (2)
- Medicinal cannabis hub (2)
- Clinical trials (1)
- Unique Device Identification (UDI) hub (1)
- Vaping hub (1)
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281 result(s) found, displaying 176 to 200
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ConsultationThe Secretary invites public submissions on these late additions to the scheduling proposals referred to the June 2019 meeting of the ACCS. Closing date: 24 May 2019
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ConsultationProposed amendments to the Poisons Standard are now available for public comment. Closing date 13 May 2019
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ConsultationConsultation on a proposed new rule for classifying inhalation devices, seeking feedback to align with EU standards and improve safety and regulation.
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ConsultationThis 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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ConsultationThis 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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ConsultationConsultation on proposed changes to classify active implantable medical devices and accessories, aligning Australian rules with EU regulations.
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ConsultationConsultation on proposed changes to classify medical devices used in direct contact with the heart, central circulatory or nervous systems.
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ConsultationThrough a targeted consultation, the TGA invited views of a number of stakeholders on proposed options for process improvements
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ConsultationThe 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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ConsultationThe TGA sought feedback on how personalised medical devices are regulated in Australia. Closing date: 31 March 2019
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ConsultationThis consultation paper considers the EU regulatory framework as an input into the review and reform of the Australian regulatory requirements for medical devices classification.
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ConsultationThe TGA sought feedback on how software, including Software as a Medical Device, is regulated in Australia.
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ConsultationThe TGA is seeking comments from interested parties on Options for the Regulation of Faecal Microbiota Transplantation materials.
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ConsultationWe 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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ConsultationThe TGA seeks comments on the extent to which a similar approach will be appropriate in the Australian regulatory context. Closing date: 18 February 2019.
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ConsultationThe 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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ConsultationThe 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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ConsultationInvitation 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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ConsultationProposed Amendments to the Poisons Standard are now available for public comment. Closing date: 21 January 2019
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ConsultationDiscussion paper outlining different approaches to access and safety controls for alkyl nitrites
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ConsultationConsultation on proposed regulation of IVD companion diagnostics, seeking stakeholder feedback to inform a framework for safe and effective evaluation alongside related therapies.
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ConsultationAdvisory Committee on Medicines Scheduling to consider upscheduling of modified release paracetamol to 'Pharmacist Only'. Closing date 31 October 2018
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ConsultationThe IMDRF sought comments on a proposed guidance document and two information documents.
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ConsultationThe IMDRF sought comments on a proposed document and its annexes
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ConsultationInvitation to comment on proposed Poisons Standard amendments. Closing date: 28 September 2018