Proposed refinements to the regulation of personalised medical devices

7 June 2021 - Regulatory changes introducing a new framework for the regulation of personalised medical devices commenced on 25 ...

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ATAGI/THANZ statement provides further guidance for the AstraZeneca vaccine and narrows contra-indication

23 May 2021 - The Australian Technical Advisory Group on Immunisation and the Thrombosis and Haemostasis Society of Australia and New ...

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TGA weighs over the counter contraceptive pill plan

17 May 2021 - The nation’s medicines regulator is looking at a plan to give Australians more freedom to access ...

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Medicines Australia updated position on intellectual property (in light of TRIPS waiver)

6 May 2021 - Medicines Australia continues to express our sympathies to all those affected by the pandemic. The importance ...

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Australia has backed a global push to fast-track generic COVID-19 jabs

6 May 2021 - The Morrison government has joined an international push to fast-track the production of generic COVID-19 jabs, ...

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The TGA claims Tenofovir Emtricitabine Sandoz is a first generic but is it?

22 April 2021 - Closer examination suggests otherwise. ...

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AstraZeneca ChAdOx1-S COVID-19 vaccine

16 April 2021 - Third Australian case of thrombosis with thrombocytopenia likely linked to vaccine. ...

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Batch release assessment of COVID-19 vaccines

14 April 2021 - The Therapeutic Goods Administration ensures there is an independent quality assessment of every batch of vaccine supplied ...

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‘Before end of this year’: Novavax COVID vaccine could be months away

8 April 2021 - Regulatory approvals for the third pillar of Australia’s vaccine strategy may not be obtained until the ...

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TGA to review advertising of stem cell therapies to the Australian public

7 April 2021 - The Therapeutic Goods Administration, part of the Department of Health, is investigating the advertising of stem ...

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New legislation to support medicine substitutions

5 March 2021 - New legislation has been passed to allow pharmacists to substitute a different medicine when a patient's ...

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TGA adopts Access Consortium guidance for fast-tracking authorisations of modified COVID-19 vaccines for variant

5 March 2021 - TGA has adopted guidance developed by the Access Consortium - a coalition of regulatory authorities from ...

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TGA reviewing COVID-19 tests to rule out issues diagnosing variants

24 February 2021 - Adjunct Professor John Skerritt has tasked the nation’s medical regulator with ensuring COVID-19 tests are successfully ...

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TGA bans Pfizer, AstraZeneca brand mentions in COVID-19 vaccine advertising

24 February 2021 - Pharmacies, GPs and healthcare organisations will be banned from displaying advertisements identifying whether they are using ...

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Clinical decision support software

18 February 2021 - From 25 February 2021, the way that software-based medical devices are regulated in Australia will change. ...

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