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tga.gov.au

TGA - Guidance

Get the latest updates from TGA - Guidance directly as they happen.

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Latest posts

Last updated about 1 month ago

Advertising therapeutic goods on social media

about 1 month ago

This guidance aims to help advertisers understand the legislative requirements for advertising...

Supplying therapeutic vapes in pharmacies

2 months ago

Learn about the regulatory requirements for dispensing and supplying vapes.

Supplying therapeutic vapes in pharmacies

2 months ago

This guidance outlines pharmacists’ regulatory responsibilities when supplying therapeutic vapes to support...

Understanding nitrosamine risk in listed medicines

2 months ago

Information for sponsors and manufacturers on assessing the risk of potential nitrosamine...

Understanding the medical device application audit process

3 months ago

This guidance is for sponsors of applications for inclusion of medical devices...

Understanding selection criteria for medical device application audits

3 months ago

Guidance for sponsors of medical devices seeking to include a medical device...

Reporting of medical device adverse events by healthcare facilities

4 months ago

Guidance for healthcare facilities, including information about the requirements for data fields...

TGA instructions for disinfectant testing

4 months ago

Guidance on testing of disinfectants and sterilants so they meet quality, safety...

Complying with changes to the Permissible Ingredients Determination

5 months ago

Guidance to help sponsors comply with changes to the Permissible Ingredients Determination.

Changing the sponsor of a therapeutic good

5 months ago

Guidance for what to do if the sponsor of a therapeutic good...

Determining if your product is a cosmetic, a biological or a blood component

6 months ago

If your product contains human cells and tissues (HCT), this guidance outlines...

Understanding regulatory requirements for in vitro diagnostic (IVD) companion diagnostics (CDx)

7 months ago

Guidance on the regulatory framework for in vitro diagnostic (IVD) companion diagnostics...