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New TGA framework to redefine personalised medical devices

This post will cover the recent changes brought to regulation of personalised medical devices, under a new TGA...

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TGO 91 and TGO 92 – are your labels ready?

Sponsors should check that their medicine labels comply with the relevant...

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Does social prescribing impact broader health outcomes?

Whilst the term may be relatively new to mainstream practice in Australia, the idea is...

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Coronavirus (COVID-19): Information on medicines and medical devices supply in Australia

Access the latest information about the special regulatory requirements for the supply of medicines and devices (including exemptions) in Australia during the...

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Improved Consumer Medicine Information template

The TGA have now released implementation dates for the updated Consumer Medicine Information (CMI)...

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Pandemic disruption and a new MA code update; what for patient programs in this new era?

COVID-19 has taught us that in times of uncertainty, people seek information and...

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Hand sanitiser – What do you need to know to supply in Australia?

The COVID-19 pandemic has seen the TGA rapidly changing the regulatory landscape for in-demand products that can help reduce the spread of the virus. Given all the changes taking place,...

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Brexit – What’s the impact on medicines and medical devices supplied in Australia?

A transition period is now in effect until the end of 2020 with the possibility for extension. Its status quo for Australia during the transition period, with the current regulations for...

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Patient programs for improved patient outcomes

In the digital age of present, patients have never been better equipped with the devices and technologies to take control of their own healthcare needs and outcomes....

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Making the most of complementary medicines reforms

In March this year the TGA finally started rolling out the long awaited Complementary Medicine...

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Life Saving Drugs Program: new lease on life, or on life support?

The Life Saving Drugs Program currently provides subsidised access to patients with rare and life-threatening conditions to essential and very expensive medicines....

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What is Happening with the Provisional Approval Pathway?

When the independent review of medicines and medical devices regulation was announced the pharmaceutical sector immediately saw the opportunity for an expediated approval pathway for certain prescription...

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