28/11/2025: December 2025 - UK Approved Bodies as a comparable overseas regulator (COR)

From Monday next week sponsors will be able to choose UK Approved Bodies as a COR.

The changes to our online form for applications for inclusion will be effective from 0900hrs Monday 1 December.

Webinar - Exploring the beta version of the new TGA business services portal

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The TGA Digital Portfolio invites you to our webinar, Exploring the beta version of the new TGA business services portal, on Tuesday 2 December 2025 from 1:30 - 3:00pm (AEDT).The webinar will provide:

• Background on the TGA digital transformation

• A walkthrough of the Beta (demonstration) version of the new TBS portal highlighting the key features that we ae seeking feedback on

• An opportunity to ask questions and provide feedback

Please note: this webinar will be recorded and uploaded on the TGA website following the session. If you would like to attend the TGA Beta release webinar, please register using this link - Exploring the beta version of the new TGA business services portal

Reminders: Digital Mental Health Tools Regulatory Environment Survey

We are reviewing the regulations for software-based medical devices, including digital mental health tools (DMHTs) used to screen, diagnose, monitor and/or treat patients experiencing mental health conditions.

To support this, we are asking developers, deployers and suppliers of DMHTs to complete our DMHTs Regulatory Environment Survey. This will provide us with information about DMHTs currently available in Australia including:

• types of DMHTs available

• intended user groups

• mental health conditions DMHTs are used for

• functions performed by DMHTs.

Information collected in this survey will not be used for conducting compliance or enforcement activities

Survey link: Digital Mental Health Tools Regulatory Environment Survey - Therapeutic Goods Administration - Citizen Space

Survey closes 1 December 2025.

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We encourage you to share this survey with relevant stakeholders and your networks to ensure broad engagement.

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