Consultation Hub
Find, read and respond to recent consultations from the Therapeutic Goods Administration (TGA) and also the Office of Drug Control (ODC).
Open consultations are below. Find earlier consultations using the search bar above. We publish submissions after a consultation closes and then add our decisions.
Open Consultations and Surveys
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[DRAFT] Breast Implant Risk Management Framework
The Therapeutic Goods Administration (TGA) is seeking comments on a proposed Breast Implant Risk Management Framework. The draft framework describes how the TGA identify, communicate and manage the risks associated with breast implants and what patients can do.
Closes 26 March 2024
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Draft guidance: Review of first-in-human high-risk implantable or cardiac invasive medical device clinical trials and Investigator’s brochures for medical device clinical trials
The Therapeutic Goods Administration (TGA) is seeking feedback on two draft guidance web pages it will publish. The first page explains how the review of Clinical Trial Notifications (CTNs) for first-in-human clinical trials of the highest-risk implantable and cardiac invasive medical devices...
Closes 12 April 2024
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Public consultation on Camellia sinensis extracts, amygdalin and hydrocyanic acid in the Poisons Standard
Public consultation on amending the Poisons Standard regarding Camellia sinensis extract, amygdalin and hydrocyanic acid Suggested scheduling amendments for Camellia sinensis extracts, amygdalin and hydrocyanic acid This consultation is in relation to two...
Closes 12 April 2024
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Proposed clarification of how Clinical Decision Support System (CDSS) software is regulated
The Therapeutic Goods Administration (TGA), as part of the Australian Government Department of Health and Aged Care, regulates therapeutic goods including medicines, medical devices, and biologicals to help Australians stay healthy and safe. Ongoing reforms are undertaken by the TGA...
Closes 6 May 2024
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Companion diagnostics guidance update- public consultation
The Therapeutic Goods Administration (TGA) is seeking your feedback on the updated draft Companion Diagnostics (CDx) Guidance document. The proposed updates aim to provide sponsors and manufacturers of medicines, biologicals and IVD medical devices further clarification regarding the...
Closes 17 June 2024
Applications and Forms
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NOTIFICATION FORM: Clinical decision support software exemption
This notification form is for Australian manufacturers or sponsors of clinical decision support software, that meet the exemption criteria outlined in the Therapeutic Goods (Medical Devices) Regulations 2002 . The exemption applies to medical devices that are clinical decision...
Closes 25 December 2031
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Tool: Sponsor obligations for medical devices transitioning from the EU MDD to the EU MDR
This tool is for sponsors or agents of non-IVD medical devices included in the ARTG with a need to transition from the EU MDD to the new EU MDR to allow medical devices to continue to be supplied in Australia. This tool will assist you to determine what actions you may or may not need to take...
Closes 31 July 2029
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Form: Sponsor notification for medical devices transitioning from the EU MDD to the EU MDR
Transitioning devices This form is for sponsors or agents of non-IVD medical devices included in the ARTG with a need to transition from the EU MDD to the new EU MDR to allow medical devices to continue to be supplied in Australia. Complete this form if you are a sponsor or agent seeking to...
Closes 31 July 2029
All Closed Activities
Questionnaire for continuing panel members
We want to know what you think about the TGA so we can enhance our support for all panel members. This questionnaire should only take you about 7-10 minutes to complete. The questionnaire focuses...
AusPAR Survey
The TGA would like to know what you think about the Australian Public Assessment Reports (AusPARs) for prescription medicines. This questionnaire should only take a couple of minutes to complete...
GMP Forum 2018 - Survey
TGA Conference Evaluation online form 2018 GMP Forum 26 June 2018