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Prescription Medicine Pathways

The standard regulatory evaluation pathway in Australia for new prescription medicines involves a thorough TGA review of data demonstrating safety, efficacy +/- quality. In addition to the standard regulatory pathway...
Vaccine and Vial

Provisionally yours

The development of new medicines and expanding the use of existing medicines is a resource-intensive process, where it can take a number of years to complete the clinical trials necessary...
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Formulated ingredients and premixes: Keeping the IP of a PI

Formulated ingredients or premixes are commonly used in many medicinal products – such as inks, coatings and colourants, fragrances and flavours, dosage form bases, and triturations or extracts of active...
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Your guide to claiming temporary exemption from TGO91/92 compliance

As described in the article, Addendum to TGA Deadlines: Medicine Labelling Compliance and COVID-19, 31 August 2020 marked the end of the medicines packaging reform transition. The intent of the...
Pathways

Australian Prescription Medicine Pathways – Project Orbis

Project Orbis is an initiative of the US FDA Oncology Centre of Excellence (OCE). The intent of Project Orbis is to provide a framework for concurrent submission and review of...
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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...

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