Blog
RSS FeedPosted by Michael Wonder on 23 Jan 2018
Registration of new chemical entities in Australia (update)
23 January 2018 - The TGA's publication of registration milestone dates facilitates more meaningful international comparisons. ...
Posted by Michael Wonder on 14 Jan 2018
Distributions and what to do when they are non-normal
15 January 2018 - Medical researchers often want to find out how medically relevant outcomes are related to other factors. ...
Posted by Michael Wonder on 11 Jan 2018
Black Triangle Scheme - information for sponsors
11 January 2018 - The eligibility of a product for inclusion in the scheme will be considered in the Risk Management ...
Posted by Michael Wonder on 12 Dec 2017
It’s the law, not the Code – MA’s Director of Ethics and Compliance – Deborah Monk
12 December 2017 - The Director of Ethics and Compliance at Medicines Australia Ms Deborah Monk is troubled that there ...
Posted by Michael Wonder on 20 Nov 2017
TGA business plan 2017-18
20 November 2017 - The business plan sets out the agency's product regulation, regulatory reform and international engagement agenda for 2017-18 ...
Posted by Michael Wonder on 03 Nov 2017
AusPAR content, January 2018: registration timelines
3 November 2017 - The content of AusPARs will be updated to provide increased transparency of TGA's evaluation process through ...
Posted by Michael Wonder on 26 Oct 2017
Strengthening the assessment of medical devices and information for consumers
26 October 2017 - A new regulatory framework for surgical mesh devices and provision of information to the consumers for ...
Posted by Michael Wonder on 19 Oct 2017
Open letter to Health Ministers on codeine upscheduling
19 October 2017 - Medical and health consumer advocates have published an open letter to state and territory Health Ministers, ...
Posted by Michael Wonder on 17 Oct 2017
Chemists accused of putting profits ahead of patient safety in codeine prescription row
18 October 2017 - Chemists are putting profits ahead of patient safety as they try to fight new rules that ...
Posted by Michael Wonder on 12 Sep 2017
Annual performance statistics report: July 2016 to June 2017
12 September 2017 - Since the 2015-16 report, the number of submissions received across some Category 1 application types varied significantly. ...
Posted by Michael Wonder on 07 Sep 2017
Drug makers push back on data requirements in Australia’s provisional approval pathway
5 September 2017 - A who’s who of leading drug makers have raised concerns about the proposed data requirements for ...
Posted by Michael Wonder on 06 Sep 2017
Patent term extensions in Australia: under pressure but safe for now
6 September 2017 - Government responds to the Productivity Commission Report and the Courts find “Swiss-style” claims not sufficient for ...
Posted by Michael Wonder on 06 Sep 2017
Medical devices sponsor information day - 2017
6 September 2017 - TheTGA invites medical device sponsors and their staff to attend the Medical Devices Sponsor Information Day in ...
Posted by Michael Wonder on 01 Sep 2017
Provisional approval pathway for prescription medicines
1 September 2017 - The TGA would like to thank respondents who provided submissions in response to the March 2017 ...
Posted by Michael Wonder on 28 Aug 2017
Statement on Government’s response to Productivity Commission’s inquiry in intellectual property
25 August 2017 - Medicines Australia notes the Government has today released their response to the Productivity Commission’s Inquiry in ...