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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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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Public consultation on proposed amendments to the Poisons Standard - ACMS, ACCS & Joint ACMS-ACCS, JUNE 2024
Scheduling amendments referred to expert advisory committee This consultation is for applications and delegate initiated proposals to amend the Poisons Standard. The scheduling amendments and any submissions received will be considered at the JUNE 2024 meetings of the Advisory...
Closes 22 May 2024
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Instructions For Use for Medical Devices
The Therapeutic Goods Administration (TGA) is the Australian government authority responsible for the regulation of therapeutic goods including medicines, medical devices, and biologicals to help Australians stay healthy and safe. The Therapeutic Goods Act 1989 and associated supporting...
Closes 28 May 2024
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Proposed changes to the regulation of exempt medical devices and exempt Other Therapeutic Goods
The TGA is Australia's government authority responsible for evaluating, assessing and monitoring products that are defined as therapeutic goods. The TGA regulates therapeutic goods including medicines, medical devices and biologicals to help Australians stay healthy and safe. Products that...
Closes 9 June 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