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 March 2023 meetings of the ...More
The Office of Drug Control Monitoring and Compliance Section is seeking feedback on its operational performance and engagement with Medicinal Cannabis Licence holders. The medicinal cannabis industry’s feedback will help the Monitoring and Compliance Section meet stakeholders expectations in...More
The Therapeutic Goods Administration (TGA) is seeking public comment on potential reforms to the regulation of nicotine vaping products (NVPs) in Australia.
The potential reforms are aimed at preventing children and adolescents from accessing NVPs, while supporting access to...More
The Therapeutic Goods Administration (TGA) is seeking views on medicine ingredient names that must be displayed as both the old and new ingredient name ('dual labelled') on labels and Product Information (PI) and Consumer Medicine Information (CMI) documents until 30 April 2023 as part of ...More
Scheduling amendments referred to expert advisory committee
Please note: this is a consultation for the interim decisions relating to PSILOCYBINE and MDMA ONLY. If you wish to provide comments on the other items considered at the ACMS and ACCS meetings in June 2022, please visit the...More
Scheduling amendments referred to expert advisory committee
Please note that there is a separate consultation for interim decisions relating to PSILOCYBINE and MDMA which can be found by clicking the link below:
Psilocybine and MDMA consultation
This consultation is for...More
The Therapeutic Goods Administration (TGA) is seeking feedback on the draft guidance ‘Boundary and combination products - medicines, medical devices, and biologicals ’ .
The purpose of this draft guidance is to assist sponsors and manufacturers in determining the status of...More
The Therapeutic Goods Administration (TGA) is seeking feedback on whether or not certain international scientific guidelines should be adopted.
Prior to adopting any international scientific guideline, the TGA undertakes an extensive process of internal and external...More
The Database of Adverse Event Notifications (DAEN) – medicines is the TGA’s public database displaying information about reports of suspected adverse events received in relation to medicines (including vaccines) and biological therapies in Australia.
The TGA have created a...More
The Therapeutic Goods Administration (TGA) is considering regulatory options to allow advertisers, including product sponsors, to make references to the TGA in advertising (including on product labels).
We are seeking feedback on:
whether references to the TGA should...More
Potential Scheduling amendments referred to expert advisory committee.
Please note that this consultation is for paracetamol only. If you wish to comment on other substances discussed at the November 2022 meetings, please see the link below:
Consultation for November...More
Scheduling amendments referred to expert advisory committee
Please note that this consultation does not include public submissions for paracetamol. To visit the consultation for paracetamol, please see the below link:
Paracetamol consultation hub
This...More
The Australian Government is undertaking a significant program of reform to the regulation of therapeutic goods in Australia. The reforms will continue to improve the safety, performance, and quality of medical devices in Australia and improve health outcomes for patients who require medical...More
The Therapeutic Goods Administration (TGA) is requesting feedback on the current usage of the information included with boxed injectables and whether the requirement to include a paper Product Information (PI) as a package insert in boxed injectables is still relevant for those administered by...More
Scheduling amendments referred to expert advisory committee
This consultation is for interim decisions made in relation to applications and delegate initiated proposals to amend the Poisons Standard, following advice sought at the 15-16th March 2022 meetings of the Advisory Committee on...More
The Therapeutic Goods Administration (TGA) is seeking feedback on proposed regulatory changes to strengthen safety oversight of clinical trials for medical devices. The changes are:
To increase the degree of regulatory oversight of clinical trials of certain unapproved,...More
The Therapeutic Goods Administration (TGA) is seeking feedback from interested parties on the proposed low-negligible risk changes to the Permissible Ingredients Determination . The proposed changes address the following issues:
Warning statement requiring healthcare ...More
Welcome
You are now on the Australian Unique Device Identification Database ( AusUDID) Sandpit registration page.
You can return to the UDI Hub to view other AusUDID information at any time.
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The Therapeutic Goods Administration (TGA) is seeking feedback on whether or not certain international scientific guidelines should be adopted.
Prior to adopting any international scientific guideline, the TGA undertakes an extensive process of internal and external...More
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 2022 meetings of the ...More
Prescription medicines have been used ‘off-label’ for a given indication for many years to treat conditions or uses that have not been registered in Australia. Whilst this is often aligned with accepted clinical practice, it can lead to patient inequity as it is applied in an ad hoc manner at...More
Scheduling amendments referred to expert advisory committee
This consultation is for interim decisions made in relation to applications to amend the Poisons Standard, following advice sought at the 3-4 November 2021 meetings of the Advisory Committee on Medicines Scheduling (ACMS) and the ...More
Scheduling amendments referred to expert advisory committee
This consultation is for interim decisions made in relation to applications and delegate initiated proposals to amend the Poisons Standard, following advice sought at the 23-25 June 2020 meetings of the Advisory Committee on...More
The Therapeutic Goods Administration (TGA) is seeking feedback on the updated ‘Listed medicines evidence guidelines – How to demonstrate efficacy for listed medicines’ (the Guidelines), which is intended to replace the existing ‘ Evidence guidelines – Guidelines on the evidence...More
The Therapeutic Goods Administration (TGA) is seeking feedback on a proposed priority pathway for assessment of certain novel and life-saving biologicals .
The proposed 'Priority Review' pathway will align with the pathway in place for medicines and offer a faster formal assessment pathway...More
The Therapeutic Goods Administration (TGA) is conducting a public consultation to provide industry and other interested stakeholders with an opportunity to comment on options for the TGA’s proposed fees and charges for the 2022-23 financial year. Specifically, we are seeking feedback on the...More
The Therapeutic Goods Administration (TGA) monitors the safety of medicines (including vaccines) by collecting and assessing reports of adverse events and taking regulatory action to improve medicine safety. The sponsors of medicines in Australia also have pharmacovigilance responsibilities,...More
The Therapeutic Goods Administration (TGA) is seeking feedback on whether or not certain international scientific guidelines should be adopted.
Prior to adopting any international scientific guideline, the TGA undertakes an extensive process of internal and external...More
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 15-17 March 2022 meetings of the ...More
The Therapeutic Goods Administration (TGA) is seeking feedback on whether an amendment to the Therapeutic Goods Regulations 1990 is required in order to improve patient access to critical medicines in acute-care settings.
The current regulatory framework does not permit hospital...More