AUSTRALIAN DEPT. OF HEALTH

The TGA has expanded the range of international assessments and approvals from comparable overseas regulators that sponsors can choose to...

The Therapeutic Goods Administration (TGA) is aware that some European countries have paused vaccination with the AstraZeneca ChAdOx1-S COVID-19...

Frequently asked questions V1.0 February 2021 Page 2 of 19 Copyright © Commonwealth of Australia 2021 This work is copyright. You may reproduce...

Three dimensional (3-D) printing (an additive manufacturing process), is a process where computer-aided-design (CAD) software or a 3-D scanner...

The COVID-19 pandemic has had a significant impact on regulatory bodies and business organisations around the world. Travel restrictions and...

Some medicines make country of origin claims, however there is no requirement for a medicine to display the country of origin on the label. The...

A notice about the implications of adopting the PIC/S Guide to GMP PE009-14 Description The TGA will adopt the current version of the PIC/S...

The TGA thanks respondents who provided a submission in response to the public consultation paper, Scope of Regulated Software based products,...

22 May 2020: Updated to include: temperature measuring devices, such as those used for screening people in public places that include an...

COVID-19 infections are diagnosed using tests called in vitro diagnostic medical devices (IVDs). The Therapeutic Goods Administration (TGA) is...