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.

Stethoscope with Australia flag background. - Image — Australia wants clearer distinctions between different therapeutic products • Source: Shutterstock

Medtech and pharma 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...