The TGA is seeking feedback, via online survey closing 20 November 2022, on the draft guidance ‘Boundary and combination products - medicines, medical devices, and biologicals’. 

The existing guidance is out of date and requires updating to reflect significant changes in the regulation of therapeutic goods since 2005. The purpose of the draft guidance is to assist sponsors and manufacturers in determining the status of therapeutic goods that may not fit clearly within existing definitions for medicines, biologicals, or medical devices, providing clarity on which regulatory pathway is appropriate for therapeutic goods which are considered Boundary and combination products.

The draft guidance also reflects the recent changes to Class 1 medical devices, as part of the ongoing medical device reforms, and raises other areas relevant to listed and complementary medicines such as head lice, lozenges and nail fungus products.  

Please read today’s full tech alert for more information, including a comparison of the 2005 guidance and the draft guidance, and details on how to respond to the consultation.