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 ...

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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 ...

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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 ...

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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. ...

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Progressing the long-term plan for stem cell research

2 October 2019 - This is the next step in the $150 million Stem Cell Therapies Mission, helping world-class Australian researchers ...

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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 ...

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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 ...

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Clinical trials to combat reproductive cancers

9 September 2019 - The Australian Government is investing up to $15 million in targeted clinical trials to improve treatments and ...

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$32 million available to support vital translational health

5 September 2019 - The Australian Government is opening the door for Australian researchers through a $32 million investment that will ...

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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 ...

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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 ...

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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. ...

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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 ...

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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 ...

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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 ...

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