Australia Proposes New Guidance On Regulating Boundary & Combination Products

The Australian regulator wants to hear stakeholders’ views on proposals to help decide whether a product is a medicine, a medical device or a biological – or none of the above.

hand of a hospital medical expert shows the pill to be taken to his patient. concept of generical pills
Australia wants clearer distinctions between different therapeutic products • Source: Shutterstock

Pharma and medtech companies operating in Australia have just over three weeks to comment on draft Australian guidance on how to choose the most appropriate regulatory pathway for products that do not clearly fit within the existing definitions for medicines, biologicals or medical devices.

The new guidance, which has been drafted by the Therapeutic Goods Administration, is intended to replace the existing guideline on “device-medicine boundary products,” which dates from November 2005 and...

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