Blog
RSS FeedPosted by Michael Wonder on 13 Sep 2021
Joint statement of support for an Australian Patent Box
13 September 2021 - Australia’s health innovators support the introduction of a Patent Box, and we welcome this initiative by the ...
Posted by Michael Wonder on 12 Aug 2021
Reclassification of software based medical devices
12 August 2021 - Recent changes to regulation of software based medical devices came into effect in early 2021, which ...
Posted by Michael Wonder on 11 Aug 2021
New Alzheimer's drug aducanumab is dividing doctors and patients, as the TGA weighs up its risk-benefit profile
12 August 2021 - After a decades-long career as a biology teacher, John Rodgers applies the strict logic of a ...
Posted by Michael Wonder on 09 Aug 2021
COVID-19 vaccine: international collaboration
6 August 2021 - The Therapeutic Goods Administration has strong working relationships with a wide range of international agencies and ...
Posted by Michael Wonder on 26 Jul 2021
TGA international engagement strategy 2021-2025
26 July 2021 - The TGA's International Engagement Strategy 2021-2025 describes how working with our international regulatory counterparts will benefit Australians ...
Posted by Michael Wonder on 20 Jul 2021
Streamlining proprietary ingredient categories
20 July 2021 - To help make the medicines application process more efficient, the TGA no longer allocates proprietary ingredient ...
Posted by Michael Wonder on 20 Jul 2021
Clinical trial national approach will benefit patients and our economy
20 July 2021 - Medicines Australia welcomes the clinical trial ‘one-stop-shop’ consultation, recently announced by the Australian Commission on Safety ...
Posted by Michael Wonder on 15 Jul 2021
ATAGI update following weekly COVID-19 meeting (14 July 2021)
15 July 2021 - An update from the Australian Technical Advisory Group on Immunisation (ATAGI) following their weekly meeting on 14 ...
Posted by Michael Wonder on 05 Jul 2021
Statement for health care professionals: how COVID-19 vaccines are regulated for safety and effectiveness
5 July 2021 - Joint Statement from the International Coalition of Medicines Regulatory Authorities and World Health Organization. ...
Posted by Michael Wonder on 05 Jul 2021
Medical devices reforms: enhancements to post-market monitoring
5 July 2021 - This project has been established to enhance the adverse event reporting processes. ...
Posted by Michael Wonder on 24 Jun 2021
TGA grants provisional determination for the Moderna COVID-19 vaccine, Elasomeran
24 June 2021 - Today, the Therapeutic Goods Administration granted provisional determination to Moderna Australia in relation to the COVID-19 ...
Posted by Michael Wonder on 23 Jun 2021
Fees and charges: summary from 1 July 2021
23 June 2021 - The TGA is required to recover its costs for all activities that fall within the scope of ...
Posted by Michael Wonder on 22 Jun 2021
Australia-Canada-Singapore-Switzerland-United Kingdom (Access) Consortium
22 June 2021 - The TGA is a member of the Access consortium along with Health Canada, Health Sciences Authority of ...
Posted by Michael Wonder on 17 Jun 2021
COVID-19 vaccine weekly safety report (17 June 2021)
17 June 2021 - Twelve additional cases of blood clots with low blood platelets have been assessed as thrombosis with thrombocytopenia ...
Posted by Michael Wonder on 10 Jun 2021
COVID-19 vaccine weekly safety report (10 June 2021)
10 June 2021 - Seven additional cases of blood clots with low blood platelets have been assessed as thrombosis with ...