Blog
RSS FeedPosted 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 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 ...
Posted by Michael Wonder on 24 Aug 2017
Major new measures to help combat rare cancers
24 August 2017 - The Australian Government is supporting major new initiatives that will improve access to clinical trials, particularly for ...
Posted by Michael Wonder on 16 Aug 2017
Amicus Therapeutics announces approval for Galafold (migalastat) for treatment of Fabry disease in Australia
15 August 2017 - First Amicus medicine and first oral precision medicine for Fabry disease in Australia. ...
Posted by Michael Wonder on 15 Aug 2017
Access to unregistered drugs in Australia
15 August 2017 - Drugs can usually only be prescribed for patients if they have been approved by the Therapeutic ...
Posted by Michael Wonder on 01 Aug 2017
Nomenclature of biological medicines
28 July 2017 - The TGA is seeking comments from interested parties on proposed options on whether there is a need ...
Posted by Michael Wonder on 27 Jul 2017
Cancer drug secures $400m royalty deal
27 July 2017 - Melbourne’s Walter and Eliza Hall Institute of Medical Research has landed one of the biggest research ...
Posted by Michael Wonder on 19 Jul 2017
Greens ban cancer medicine, gender in new sweeping policy platform
20 July 2017 - The Greens have plans to cut off production of cancer medications and remove questions about “gender” ...
Posted by Michael Wonder on 18 Jul 2017
Roche’s Ocrevus (ocrelizumab) approved for relapsing and primary progressive multiple sclerosis in Australia
17 July 2017 - Second approval after the US for Ocrevus as the first and only approved treatment for people with ...
Posted by Michael Wonder on 11 Jul 2017
TGA to be one-stop shop for complaints
10 July 2017 - The TGA will be given full responsibility over advertising complaints for medicines and medical devices in ...
Posted by Michael Wonder on 10 Jul 2017
TGA to improve the handling of advertising complaints
10 July 2017 - Australia’s therapeutic goods regulator is implementing new arrangements to simplify and improve the handling of complaints about ...
Posted by Michael Wonder on 04 Jul 2017
Cost recovery implementation statement 2017-18
4 July 2017 - This Cost Recovery Implementation Statement provides information on how the TGA implements cost recovery activities associated with ...
Posted by Michael Wonder on 03 Jul 2017
Authorised prescribers
3 July 2017 - The Government accepted the Expert Review of Medicines and Medical Devices Regulation recommendation to make changes ...