What it takes to get a new drug to market in Australia

In this latest version of ThematicInsights from The Market Online, we’re taking a break from mining and battery science to look at the healthcare sector once again.

This time around, we’re looking at the ASX-listed pharmaceutical space.

Our readers wanted to know what it takes for a company to list a new drug in the Australian market – a complicated process.

To that end, this report looks at what companies must do under the Australian drug regulator to bring a new product to pharmacy or supermarket shelves.

Our domestic regulator is the Therapeutic Goods Administration (TGA) – think of it as the lesser known cousin to the US Food and Drug Administration (FDA).

This report describes the TGA-regulated clinical trial process, ethics and legal considerations companies must satisfy, and other steps on the path to final approval.

Finally, this article looks at a number of companies in the space who are progressing medical technologies in Australia under the TGA regime.

What this report is designed to afford the reader an understanding of the ins-and-outs of the Australian pharmaceutical regulatory landscape.

Click here to read the latest Thematic Insights.

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