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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Public consultation on interim decisions to amend the Poisons Standard - ACMS, ACCS & Joint ACMS-ACCS JUNE, 2024
Interim decisions regarding substances discussed at the expert advisory meetings. This consultation is for interim decisions made in relation to substances that were discussed at the JUNE 2024 meetings of the Advisory Committee on Medicines Scheduling (ACMS) and the Advisory Committee on...
Closes 18 October 2024
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Clarifying and strengthening the regulation of Artificial Intelligence (AI)
Artificial Intelligence (AI) has already made a difference to many lives, providing the potential to solve problems faster, and opening up opportunities to get things done in smarter and better ways. If safely deployed, its development and adoption can improve wellbeing, quality of life and...
Closes 20 October 2024
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Public consultation on proposed amendments to the Poisons Standard - ACMS, ACCS & Joint ACMS-ACCS, November 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 November 2024 meetings of the ...
Closes 22 October 2024
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Consultation: Future regulation of assistive technologies
The TGA is seeking feedback on proposed changes to the regulation of assistive technologies. The TGA is Australia's government authority responsible for evaluating, assessing, and monitoring products that are defined as therapeutic goods including medicines, medical...
Closes 31 October 2024
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Australian Medical Device Essential Principles - Part 2: Proposed alignment with the European Regulation
UPDATE: Our response to questions asked during the consultation presentation on 11-12 September 2024 has been added to the related documents below the other consultation document links. We have also included a link to the presentation slides. The Therapeutic Goods Administration (TGA) is the...
Closes 13 November 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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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
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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
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