Find, share and participate in consultations from the Therapeutic Goods Administration that interest you.
Browse our open consultations below, or search for consultations in the search bar above. Once finalised, decisions will be published under closed consultations.
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
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
Potential Scheduling amendments referred to expert advisory committee.
This consultation is for possible delegate-initiated proposals to amend the Poisons Standard with regards to paracetamol. The suggested amendments and any submissions received will be considered at the ...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
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 2022 meetings of the ...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
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 Australian Government is undertaking a significant program to reform the regulation of therapeutic goods in Australia. As part of the Australian Government Department of Health, the Therapeutic Goods Administration (TGA) regulates therapeutic goods, and is responsible for implementing the...More