The TGA has published new guidance on boundary and combination products.

The guidelines were updated following public consultation in Oct-Nov 2022, as the previous guidance was out of date and required updating to reflect significant changes in the regulation of therapeutic goods since 2005.

The new guidelines discuss key concepts that aim to assist manufacturers and sponsors to understand which regulatory pathways and requirements will apply to boundary and combination products, depending on how they are categorised. 

Please read today’s alert for more details.