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) (68)
- Medical devices (62)
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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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212 result(s) found, displaying 101 to 125
- Closed onConsultationConsultation: Proposed changes to medical device essential principles for safety and performanceThe TGA is seeking comments on the proposed changes to the essential principles for safety and performance of medical devices. Closing date: 17 October 2019
- Closed onConsultationIMDRF consultation: Good Regulatory Review Practices - Requirements for Conformity Assessment BodiesDraft IMDRF document. Closing date: 3 October 2019
- Closed onConsultationConsultation: Changes to permissible ingredients - Low-negligible riskThese proposed ingredient changes have been reviewed and categorised as being of low-negligible risk. Closing date: 11 October 2019
- Closed onConsultationConsultation: Proposed clarification that goods are therapeutic goods - goods containing folate substances in certain circumstancesThe 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
- Closed onConsultationConsultation: Proposed amendments to the Poisons Standard - ACMS and ACCS, November 2019The Secretary invites public submissions on the scheduling proposals referred to the November 2019 meetings of the ACMS and ACCS. Closing date: 26 September 2019
- Closed onConsultationConsultation on the new Therapeutic Goods Order 106 - Data matrix codes and serialisation of medicinesThe 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.
- Closed onConsultationIMDRF consultation: Personalised Medical Devices - Regulatory PathwaysThe TGA invites interested parties to comment on the IMDRF consultation document. Closing date: 24 July 2019
- Closed onConsultationTargeted consultation: Review of chemical scheduling in relation to cosmetic and fragrance ingredientsThrough a targeted consultation, the TGA invited views of a number of stakeholders on proposed options for process improvements
- Closed onConsultationConsultation: Proposed amendments to the Poisons Standard - ACCS meeting, June 2019The 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
- Closed onConsultationConsultation: Proposed amendments to the Poisons Standard - ACCS, ACMS and Joint ACCS/ACMS meetings, June 2019Proposed amendments to the Poisons Standard are now available for public comment. Closing date 13 May 2019
- Closed onConsultationConsultation: Proposed changes to the classification of active implantable medical devices and their accessoriesThis 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
- Closed onConsultationConsultation: Proposed changes to the classification of medical devices used in direct contact with the heart, central circulatory or central nervous systemsThis 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
- Closed onConsultationConsultation: Proposed medical device classification for human cells, tissues and organs storage solutions and IVF mediaThis 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
- Closed onConsultationConsultation: Proposed new classification rule for medical devices that administer medicines or biologicals by inhalationThis 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
- Closed onConsultationConsultation: Proposed new medical device classification for substances introduced into the body via a body orifice or applied to the skinThis 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
- Closed onConsultationConsultation: Proposed criteria for Appendix M of the Poisons Standard to support rescheduling of substances from Schedule 4 (Prescription only) to Schedule 3 (Pharmacist only)The 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
- Closed onConsultationConsultation: Proposed regulatory scheme for personalised medical devices, including 3D-printed devicesThe TGA sought feedback on how personalised medical devices are regulated in Australia. Closing date: 31 March 2019
- Closed onConsultationConsultation: Regulation of software, including Software as a Medical Device (SaMD)The TGA sought feedback on how software, including Software as a Medical Device, is regulated in Australia. Closing date: 31 March 2019
- Closed onConsultationConsultation: Proposed reclassification of spinal implantable medical devicesThis 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
- Closed onConsultationConsultation: Changes to a number of definitions and the scope of the medical device regulatory framework in AustraliaThe 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
- Closed onConsultationConsultation: Potential reclassification of active medical devices for diagnosis and patient therapyThe 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 onConsultationConsultation: Proposal to introduce a Unique Device Identification (UDI) system for medical devices in AustraliaWe 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
- Closed onConsultationConsultation: Proposed amendments to the Poisons Standard - ACCS meeting, March 2019Invitation to comment on proposed amendments to the Poisons Standard - ACCS, March 2019 (late addition to the published agenda). Closing date: 8 February 2019
- Closed onConsultationConsultation: Medical device cyber securityThe 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
- Closed onConsultationConsultation: Proposed amendments to the Poisons Standard - ACCS, ACMS and Joint ACCS/ACMS meetings, March 2019Proposed Amendments to the Poisons Standard are now available for public comment. Closing date: 21 January 2019