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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Consultation: Legislating regulatory categories for some boundary and combination products
The Australian Government is undertaking significant reforms to further improve regulation of therapeutic goods in Australia. The Therapeutic Goods Administration (TGA) is the government authority responsible for evaluating, assessing and monitoring products that are defined as therapeutic goods...
Closes 6 August 2024
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Consultation on a proposed exposure model for assessing the safety of sunscreen ingredients in Australia
The Therapeutic Goods Administration (TGA) is seeking public comment on proposed models to estimate sunscreen use (exposure) by Australians which will be used to calculate the maximum safe concentration of sunscreen ingredients. The options proposed for stakeholder consideration...
Closes 13 August 2024
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Reforming Australia's Therapeutic Goods Testing Regulations
The Therapeutic Goods Administration (TGA) is responsible for protecting the health and safety of the community by regulating therapeutic goods for safety, efficacy, performance, and quality. We do this through the application of the Therapeutic Goods Act 1989 (the Act), the Therapeutic Goods...
Closes 18 August 2024
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Public consultation on interim decisions to amend the Poisons Standard - ACMS, ACCS & Joint ACMS-ACCS MARCH, 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 MARCH 2024 meetings of the Advisory Committee on Medicines Scheduling (ACMS) and the Advisory Committee...
Closes 23 August 2024
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Consultation on the sunsetting Therapeutic Goods Order No.70C - Standards for Export Only Medicine
Therapeutic Goods Order No. TGO 70C (TGO 70C) – Standards for Export Only Medicine ( https://www.legislation.gov.au/F2014L00683/asmade/text ) is a relevant standard for therapeutic goods which are listed for export only in the Australian Register of Therapeutic Goods (ARTG). TGO 70C is due to...
Closes 26 August 2024
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Revision of the guidance document TGA Instructions for Disinfectant Testing
The Therapeutic Goods Administration (TGA) is seeking feedback on a revised version of the guidance document ‘TGA Instructions for Disinfectant Testing’. The TGA Instructions for Disinfectant Testing are a regulatory tool, used to provide guidance to sponsors and applicants as to what...
Closes 30 August 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