Blog
RSS FeedPosted by Michael Wonder on 21 Nov 2019
FDA takes second action under international collaboration, approves new treatment option for patients with chronic lymphocytic leukaemia
21 November 2019 - Today, as part of Project Orbis, a collaboration with the Australian Therapeutic Goods Administration and Health Canada, ...
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 14 Oct 2019
STA to market sarcoma drug in Australia, New Zealand and SE Asia following license deal
14 October 2019 - Specialised Therapeutics now filing for TGA approval. ...
Posted by Michael Wonder on 25 Sep 2019
TGA approves drug to fight ovarian cancer
26 September 2019 - Some women diagnosed with ovarian cancer could have their survival rates significantly increased after the Therapeutic ...
Posted by Michael Wonder on 17 Sep 2019
Provisional approval of lenvatinib in combination with pembrolizumab for the treatment of advanced endometrial carcinoma
18 September 2019 - The Therapeutic Goods Administration has provisionally approved the use of lenvatinib (Lenvima) in combination with pembrolizumab ...
Posted by Michael Wonder on 03 Sep 2019
The TGA launches new tool to help sponsors find information on registering prescription medicines
3 September 2019 - Today the Therapeutic Goods Administration launched a new tool to assist users with finding information within ...
Posted by Michael Wonder on 28 Aug 2019
Australian Public Assessment Reports for prescription medicines
28 August 2019 - TGA is reviewing the operation of transparency measures and are considering activities to increase transparency of ...
Posted 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 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 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 ...