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.
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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- Scheduling (national classification system) (72)
- Therapeutic goods regulation (18)
- Over the counter (OTC) medicines (14)
- Prescription medicines (13)
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- Complementary medicines (9)
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- In Vitro Diagnostic medical devices (IVDs) (3)
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238 result(s) found, displaying 126 to 150
- 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: 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
- 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
- IMDRF consultation: Good Regulatory Review Practices - Requirements for Conformity Assessment BodiesClosed onConsultationDraft IMDRF document. Closing date: 3 October 2019
- Consultation: Increased online access to ingredient informationClosed onConsultationWe are seeking feedback on a proposal to publish the names of excipient ingredients used in therapeutic goods in the public view of the Australian Register for Therapeutic Goods (ARTG).
- 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
- 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
- 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: 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
- 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 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
- Consultation: Potential reclassification of active medical devices for diagnosis and patient therapyClosed 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
- Consultation: Proposal to introduce a Unique Device Identification (UDI) system for medical devices in AustraliaClosed 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
- Consultation: Proposed amendments to the Poisons Standard - ACCS meeting, March 2019Closed onConsultationInvitation to comment on proposed amendments to the Poisons Standard - ACCS, March 2019 (late addition to the published agenda). Closing date: 8 February 2019
- Consultation: Medical device cyber securityClosed 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