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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Medicines Australia statement on TGA’s provisional approval of AstraZeneca’s COVID-19 vaccine

16 February 2021 - Medicines Australia welcomes the TGA’s decision granting provisional approval of the AstraZeneca/Oxford University COVID-19 vaccine, marking ...

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TGA provisionally approves AstraZeneca's COVID-19 vaccine

16 February 2021 - The Therapeutic Goods Administration has granted provisional approval to AstraZeneca for its COVID-19 vaccine, making it ...

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TGA approves new formulation of glatiramer acetate

16 February 2021 - The TGA thinks glatiramer acetate (Glatopa) is a new chemical entity. ...

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One billion dollar bid to go it alone with COVID-19 vaccine hub

15 February 2021 - A proposal for a state-of-the-art $1 billion facility to manufacture vaccines and prescription drugs in Australia ...

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COVID-19 vaccine shipment could arrive in Australia as early as next week

11 February 2021 - Coronavirus vaccines are a step closer to arriving in Australia after the European Commission formally approved ...

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CSL confident it can make vaccine to cover variants, if needed

11 February 2021 - CSL is confident it can make an updated version of AstraZeneca’s COVID-19 vaccine to cover any ...

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It will be six years before the world is vaccinated against COVID-19: experts

10 February 2021 - It will take six years to vaccinate enough of the world’s population to reduce the threat ...

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Pfizer vaccine bound for Australia won’t be blocked

9 February 2021 - Europe will not delay the first doses of Pfizer vaccine bound for Australia despite moves to block ...

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COVID-19 vaccine certificates to be available online within days of immunisation

8 February 2021 - Australians will have access to their COVID-19 immunisation certificates within days of receiving the vaccine, with ...

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TGA one of only five non-European regulators invited to participate on European committees on COVID-19 vaccines and therapeutics

8 February 2021 - Australia, through the TGA, is one of only five non-European Union regulators formally invited to participate ...

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