Product Information

12 October 2017 - Changes make critical clinical information easier to find. ...

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Annual performance statistics report: July 2016 to June 2017

12 September 2017 - Since the 2015-16 report, the number of submissions received across some Category 1 application types varied significantly.  ...

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Meningococcal vaccine approved for infants

11 September 2017 - A vaccine that protects very young children against four strains of meningococcal has been approved by the ...

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Medical technology investment to improve lives

11 September 2017 - The Australian Government will fund three medical breakthroughs to help people with severe disabilities walk again ...

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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 ...

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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 ...

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Medical devices sponsor information day - 2017

6 September 2017 - TheTGA invites medical device sponsors and their staff to attend the Medical Devices Sponsor Information Day in ...

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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 ...

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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 ...

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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 ...

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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. ...

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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 ...

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Nomenclature of biological medicines

28 July 2017 - The TGA is seeking comments from interested parties on proposed options on whether there is a need ...

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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 ...

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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” ...

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