24 June 2021
The TGA has granted a number of provisional determinations in relation to COVID-19 vaccines.
17 June 2021
Find information on complying with the rules around advertising and importing COVID-19 vaccines
3 June 2021
The TGA has issued two infringement notices to Perth-based company V P & Associates Pty Ltd (V P & Associates), for alleged unlawful advertising of a medical device in relation to SARS-CoV-2 Human Coronavirus.
21 May 2021
The TGA granted a provisional determination to GlaxoSmithKline Australia Pty Ltd in relation to the monoclonal antibody treatment, SOTROVIMAB (GSK4182136) on 14 April 2021
12 May 2021
The granting of this determination means that Pfizer is now eligible to apply to vary its provisional registration for the vaccine for use in individuals 12 years of age or older.
29 March 2021
It is alleged the company breached the Therapeutic Goods Act 1989 in relation to the importation of surgical face masks.
26 March 2021
The TGA has granted provisional approval to AstraZeneca Pty Ltd for its COVID-19 vaccine
24 March 2021
In response to the COVID-19 pandemic, the TGA has expedited approvals for inclusion of COVID-19 tests in the Australian Register of Therapeutic Goods (ARTG). The TGA has commenced validation reviews of serology-based COVID-19 point-of-care tests included in the ARTG.
11 March 2021
In response to the COVID-19 pandemic, the TGA has expedited the approval (with conditions) of COVID-19 tests including tests intended for laboratory use and those intended for use by specified health professionals at the point of care.
25 February 2021
The TGA has issued four infringement notices to Sydney-based company for the alleged unlawful importation of infrared thermometers, rigid strapping tapes and iodine prep pads.