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.
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- Scheduling (national classification system) (69)
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More on consultations
Find more scheduling consultations on the Poisons Standard in our Interim decisions.
Read the details of recent consultations, submissions and decisions at the TGA Consultation hub.
Trove at the National Library of Australia has information on archived TGA consultations and reviews.
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218 result(s) found, displaying 101 to 125
- Consultation: Review of the regulation of certain self-testing IVDs in AustraliaClosed onConsultationThe closing date of this consultation has been extended. Closing date: 6 December 2019
- Notice of an interim decision to amend the current Poisons Standard in relation to nicotine - Joint ACMS-ACCS meeting, June 2020Closed onConsultationThis consultation is for an interim decision to amend the scheduling of nicotine in the current Poisons Standard, following advice sought at the 23 June 2020 meeting of the Advisory Committee on Medicines and Chemicals Scheduling in joint session (Joint ACMS-ACCS #25, June 2020).
- Consultation: Proposed amendments to the Poisons Standard - ACMS and Joint ACCS/ACMS meetings, November 2019Closed onConsultationThe Secretary invites public submissions on the scheduling proposals referred to the November 2019 meetings of the ACMS and joint ACCS/ACMS. Closing date: 17 October 2019
- Consultation: Products used for and by people with disabilitiesClosed onConsultationTGA is seeking comments on clarification of the regulation of products used for and by people with disabilities. Closes: 25 October 2019
- Consultation: Proposed changes to medical device essential principles for safety and performanceClosed onConsultationThe TGA is seeking comments on the proposed changes to the essential principles for safety and performance of medical devices. Closing date: 17 October 2019
- IMDRF consultation: Good Regulatory Review Practices - Requirements for Conformity Assessment BodiesClosed onConsultationDraft IMDRF document. Closing date: 3 October 2019
- Consultation: Changes to permissible ingredients - Low-negligible riskClosed onConsultationThese proposed ingredient changes have been reviewed and categorised as being of low-negligible risk. Closing date: 11 October 2019
- Consultation: Proposed clarification that goods are therapeutic goods - goods containing folate substances in certain circumstancesClosed onConsultationThe TGA sought comments from interested parties on the making of an order under subsection 7(1) of the Therapeutic Goods Act 1989. Closing date 18 September 2019
- Consultation: Proposed amendments to the Poisons Standard - ACMS and ACCS, November 2019Closed onConsultationThe Secretary invites public submissions on the scheduling proposals referred to the November 2019 meetings of the ACMS and ACCS. Closing date: 26 September 2019
- Notice of interim decisions to amend (or not to amend) the current Poisons Standard - ACMS/ACCS/Joint ACMS-ACCS meeting, June 2020Closed onConsultationThis consultation is for interim decisions made in relation to applications and delegate initiated proposals to amend the scheduling in the Poisons Standard, following advice sought at the 23-25 June 2020 meetings of the Advisory Committee on Medicines Scheduling (ACMS), and the Advisory Committee on Chemicals Scheduling (ACCS).
- IMDRF consultation: Personalised Medical Devices - Regulatory PathwaysClosed onConsultationThe TGA invites interested parties to comment on the IMDRF consultation document. Closing date: 24 July 2019
- Consultation on the new Therapeutic Goods Order 106 - Data matrix codes and serialisation of medicinesClosed onConsultationThe Therapeutic Goods Administration (TGA) is seeking feedback on proposed requirements for serialisation and the use of data matrix codes on the labels of certain medicines in the Australian supply chain.
- Targeted consultation: Review of chemical scheduling in relation to cosmetic and fragrance ingredientsClosed onConsultationThrough a targeted consultation, the TGA invited views of a number of stakeholders on proposed options for process improvements
- Consultation: Proposed amendments to the Poisons Standard - ACCS meeting, June 2019Closed onConsultationThe 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
- Consultation: Proposed amendments to the Poisons Standard - ACCS, ACMS and Joint ACCS/ACMS meetings, June 2019Closed onConsultationProposed amendments to the Poisons Standard are now available for public comment. Closing date 13 May 2019
- Consultation: Proposed changes to the classification of active implantable medical devices and their accessoriesClosed 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
- Consultation: Proposed changes to the classification of medical devices used in direct contact with the heart, central circulatory or central nervous systemsClosed 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
- Consultation: Proposed medical device classification for human cells, tissues and organs storage solutions and IVF mediaClosed 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
- Consultation: Proposed new classification rule for medical devices that administer medicines or biologicals by inhalationClosed 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
- Consultation: Proposed new medical device classification for substances introduced into the body via a body orifice or applied to the skinClosed 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
- Consultation: Proposed criteria for Appendix M of the Poisons Standard to support rescheduling of substances from Schedule 4 (Prescription only) to Schedule 3 (Pharmacist only)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
- Consultation: Proposed regulatory scheme for personalised medical devices, including 3D-printed devicesClosed onConsultationThe TGA sought feedback on how personalised medical devices are regulated in Australia. Closing date: 31 March 2019
- Consultation: Regulation of software, including Software as a Medical Device (SaMD)Closed onConsultationThe TGA sought feedback on how software, including Software as a Medical Device, is regulated in Australia. Closing date: 31 March 2019
- Consultation: Proposed reclassification of spinal implantable medical devicesClosed 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
- Consultation: Changes to a number of definitions and the scope of the medical device regulatory framework in AustraliaClosed 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