Blog
RSS FeedPosted 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 ...
Posted by Michael Wonder on 07 Jun 2021
Proposed refinements to the regulation of personalised medical devices
7 June 2021 - Regulatory changes introducing a new framework for the regulation of personalised medical devices commenced on 25 ...
Posted by Michael Wonder on 24 May 2021
ATAGI/THANZ statement provides further guidance for the AstraZeneca vaccine and narrows contra-indication
23 May 2021 - The Australian Technical Advisory Group on Immunisation and the Thrombosis and Haemostasis Society of Australia and New ...
Posted by Michael Wonder on 17 May 2021
TGA weighs over the counter contraceptive pill plan
17 May 2021 - The nation’s medicines regulator is looking at a plan to give Australians more freedom to access ...
Posted by Michael Wonder on 06 May 2021
Medicines Australia updated position on intellectual property (in light of TRIPS waiver)
6 May 2021 - Medicines Australia continues to express our sympathies to all those affected by the pandemic. The importance ...