Blog
RSS FeedPosted by Michael Wonder on 26 Nov 2019
'Outrageous': banned breast implant maker flouts TGA and safety concerns
25 November 2019 - The Therapeutic Goods Administration is demanding answers from the manufacturer of a banned breast implant after ...
Posted by Michael Wonder on 11 Nov 2019
TGA approved terminology for therapeutic goods
11 November 2019 - The Therapeutic Goods Administration develops and maintains approved terminology to ensure the accuracy and consistency of ...
Posted by Michael Wonder on 24 Oct 2019
Proposed new classification rule for medical devices that administer medicines or biologicals by inhalation
24 October 2019 - The TGA thanks respondents who provided a submission in response to the public consultation paper Proposed new ...
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 01 Aug 2019
Fast track pathways for drug approvals: the Australian experience so far
1 August 2019 - In 2016, the Australian Government announced that the Therapeutic Goods Administration would establish two new pathways ...
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 ...
Posted by Michael Wonder on 26 Jul 2019
Intellectual property law amends will add to business uncertainty
26 July 2019 - Medicines Australia supports efforts to strengthen Australia’s Intellectual Property arrangements to be consistent with international best ...
Posted by Michael Wonder on 09 Jul 2019
Pharma giant using loophole to falsely promote opioid pain relief product across Australia
10 July 2019 - Debbie Thompson is a grandmother of five who likes to crochet in her spare time. The ...
Posted by Michael Wonder on 02 Jul 2019
Schedule of fees and charges
2 July 2019 - 2019-20 fees and charges schedule applies to applications submitted to the TGA on or after 1 July ...
Posted by Michael Wonder on 21 Jun 2019
Cost recovery implementation statement
21 June 2019 - The cost recovery implementation statement outlines the TGA's regulatory costs and provides detailed information on TGA's ...
Posted by Michael Wonder on 23 May 2019
TGA fees and charges: summary from 1 July 2019
23 May 2019 - The TGA is required to recover its costs for all activities that fall within the scope ...
Posted by Michael Wonder on 21 May 2019
South Africa's Aspen sells Australian prescription portfolio to Mylan
20 May 2019 - Aspen Pharmacare has said that Mylan had exercised an option to buy the South African drug ...
Posted by Michael Wonder on 15 May 2019
Sigma Healthcare to face investor questions over claims it mishandled prescription drugs
15 May 2019 - Pharmaceutical supplier Sigma Healthcare will face shareholder questions over claims that it failed to properly handle ...
Posted by Michael Wonder on 09 Apr 2019
International work-sharing initiative - abemaciclib (Verzenio)
9 April 2019 - Abemaciclib (Verzenio) is the second medicine to be registered on the Australian Register of Therapeutic Goods ...
Posted by Michael Wonder on 27 Nov 2018
The Implant Files: How the Therapeutic Goods Administration regulates medical devices
27 November 2018 - There is good reason why the building that houses Australia's powerful regulator of drugs and medical ...