The Australian Government is working to further improve regulation of therapeutic goods in Australia. The Therapeutic Goods Administration (TGA) is the government authority responsible for evaluating, assessing and monitoring products that are defined as therapeutic goods including medicines, medical devices and biologicals.
The TGA has produced Guidelines on Boundary and Combination Products (the Guidelines) to help sponsors figure out if their therapeutic goods are medicines, biologicals or medical device.
Consultation on the Guidelines received feedback that more clarity is required on whether:
- legislating some products where possible to formally declare their regulatory category (e.g., medical device, not a medical device or Other Therapeutic Good), will provide additional clarity for stakeholders; and
- a 5 year transitional period is sufficient for sponsors of affected goods.
You can provide input on the Guidelines by answering the consultation questions by 5 August 2024. | 
