Coronavirus triggers national medical stockpile as COVID-19 threat intensifies

29 February 2020 - It could be any warehouse in Australia. In fact, you may travel past it every day ...

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Independent review of the reforms to the therapeutic goods advertising framework to commence

26 February 2020 - The independent review of the advertising reforms has now commenced, and is being led by Ms Rosemary ...

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Brexit - implications for therapeutic goods in Australia

25 February 2020 - A transition period is in effect until the end of 2020 while the UK and EU negotiate ...

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Frustration as life-saving EpiPens sit in warehouses, pharmacists out of stock

19 February 2020 - The peak body for Australians with severe allergies is calling on pharmacists to stock up on ...

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Australia's biotech innovations heading offshore, prompting calls for greater funding to bring them to market

11 February 2020 - The demand on the health sector has never been more evident, as the world scrambles to ...

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Fees and charges proposal 2020-21

20 January 2020 - The TGA is undertaking a consultation through its website to seek stakeholder's views on TGA’s proposed fees ...

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New science strategy prepares regulatory scientists for the future

20 January 2020 - The Health Products Regulation Group in the Department of Health has published a new regulatory science ...

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TGA - 2019 in review

14 January 2020 - According to the TGA, it approved 34 new chemical entities in 2019. ...

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EpiPen Jr

2 December 2019 - Due to the critical nature of the ongoing EpiPen Jr shortage, the TGA is allowing one ...

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Acalabrutinib receives TGA approval for CLL and SLL cancers

25 November 2019 - The Therapeutic Goods Administration has approved the use of acalabrutinib (Calquence) for the treatment of patients ...

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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, ...

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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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