Blog
RSS FeedPosted by Michael Wonder on 14 Sep 2022
Independent review of paracetamol overdose
14 September 2022 - The TGA has published an independent expert report examining the incidence of serious injury and death ...
Posted by Michael Wonder on 17 Mar 2022
COVID-19 vaccine weekly safety report (17 March 2022)
17 March 2022 - To 13 March 2022, the TGA has received 457 reports which have been assessed as likely to ...
Posted by Michael Wonder on 19 Aug 2021
TGA reduces timeframe for publishing adverse event reports
19 August 2021 - With strong public interest in adverse event reports relating to COVID-19 vaccinations, and improvements in our ...
Posted by Michael Wonder on 08 Jul 2021
COVID-19 vaccine weekly safety report (8 July 2021)
8 July 2021 - Seven additional cases of blood clots with low blood platelets have been assessed as thrombosis with thrombocytopenia ...
Posted by Michael Wonder on 20 May 2021
COVID-19 vaccine weekly safety report
20 May 2021 - Six additional cases of blood clots with low blood platelets have been assessed as thrombosis with thrombocytopenia ...
Posted by Michael Wonder on 22 Apr 2021
TGA publishes AusPAR for Zolgensma
22 April 2021 - Rapid publication following approval. ...
Posted by Michael Wonder on 21 Jul 2020
TGA publishes AusPAR for Vemlidy
21 July 2020 - AusPAR published within days of its provisional registration; why do other take years? ...
Posted by Michael Wonder on 06 May 2020
Half yearly performance snapshot: July to December 2019
6 May 2020 - The TGA prepares an annual TGA Business Plan, which identifies the priority activities being undertaken over the ...
Posted by Michael Wonder on 20 Apr 2020
Improved Consumer Medicine Information template
20 April 2020 - The Therapeutic Goods Regulations 1990 have been amended to support improved Consumer Medicine Information. ...
Posted by Michael Wonder on 08 Apr 2020
Submissions on whether the TGA should publish that a prescription medicine is under evaluation
8 April 2020 - Between 15 February and 29 March 2019, the TGA sought comments from interested parties on the ...
Posted by Michael Wonder on 09 Mar 2020
Reformatting Product Information: frequently asked questions
6 March 2020 - A new product information form was approved on 8 November 2017, with a commencement date of ...
Posted by Michael Wonder on 19 Feb 2020
Medical device application processing times
19 February 2020 - Australia's regulatory framework for therapeutic goods is undergoing a number of changes in response to the Review ...
Posted by Michael Wonder on 21 Oct 2019
Annual performance statistics report: July 2018 to June 2019
21 October 2019 - At 30 June 2019 there were 88,788 therapeutic goods on the ARTG, including 31,987 new products added ...
Posted by Michael Wonder on 28 Aug 2019
Australian Public Assessment Reports for prescription medicines
28 August 2019 - TGA is reviewing the operation of transparency measures and are considering activities to increase transparency of ...
Posted by Michael Wonder on 30 Jul 2019
Reforms to the generic medicine market authorisation process
30 July 2019 - The TGA would like to thank respondents who provided submissions in response to the public consultation ...