Blog
RSS FeedPosted by Michael Wonder on 06 Aug 2019
Alimera announces Iluvien regulatory approval in Australia for the treatment of diabetic macular oedema
5 August 2019 - Specialised Therapeutics, an Australian biopharmaceutical company and Alimera’s distribution partner, to next seek national reimbursement. ...
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 22 Jul 2019
'I owe it everything': cancer drug approval win for rare cancers
23 July 2019 - Paul Hazelwood was told there was nothing else doctors could do to treat his rare terminal ...
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 03 Jul 2019
These two brothers are living healthier lives, thanks to gene therapy
3 July 2019 - It has taken decades of work and billions of dollars, but Australia is now entering an ...
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 01 Jul 2019
International work-sharing Initiative - niraparib (Zejula)
1 July 2019 - The TGA has approved a new drug for the treatment of some ovarian, fallopian tube, or ...
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 11 Jun 2019
Ingredient name changes: a medicine ingredient by any other name…
11 June 2019 - Consistent names are important, especially the names we use for important things like medicine ingredients. ...
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 16 May 2019
Sigma Healthcare leadership says it has received no worker reports of medicine mishandling
16 May 2019 - Sigma Healthcare's chief executive Mark Hooper has told investors that the company takes its obligations to ...
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 ...