regulatory

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Addendum to TGA Deadlines: Medicine Labelling Compliance and COVID-19

As described in the Upcoming TGA Deadlines for Medicine Labelling and Product Information Reform article the transition period for Australian Medicines Packaging Reform concludes on 31 August 2020. As a...
Medicine packaging

Upcoming TGA Deadlines for Medicine Labelling and Product Information Reform

2020 was flagged to be a big year for TGA Sponsors of Medicines with two long-standing milestones on the horizon. Whilst there is no doubt this won’t be a year...
Time passing

TGA expedites COVID-19 approvals, while keeping up business as usual for other devices

The TGA continues to provide timely responses and support for new applications and emergency use applications. Our firm continues to be in active communication with the agency, which at the...
Grant Feb artgicle image

Australian regulator closes in on Class I devices

In 2014, the Australian Government announced the Expert Panel Review of Medicines and Medical Devices Regulation, which was tasked to assess and provide feedback on the regulatory framework for medicines...

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