TGA: Draft guidance on boundary and combination products
On 08. October 2022, the Australian Therapeutic Goods Administration (TGA), published the draft guidance 'Boundary and combination products - medicines, medical devices, and biologicals’. The current guidance originally dates back to 2005. Since then, there have been significant changes in the regulation of therapeutic goods.
The Guideline is intended to help manufacturers and contracting authorities determine the status of therapeutic products. In many cases, these cannot be classified easily under the existing definitions of medicines, medical devices, and biologics. The guidance explains the key measurements for classifying a good.
Under the Therapeutic Goods Act 1989, therapeutic goods are regulated as either medicines, medical devices, or biologicals. However, in some cases, determining which definition of therapeutic goods applies to a product and which regulatory route is the correct one can be complex. There are products that could fit under more than one definition. They require more detailed review to determine which therapeutic goods definition can be applied. Such products are often referred to as "borderline" products.
In an appendix to the draft, the TGA also indicates the appropriate regulatory pathway for a list of borderline and combination products.
The draft is open for comment until November 20, 2022.
Source:
TGA: draft document
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