SME Assist

23 April 2018

Therapeutic goods regulation and legislation can be challenging to navigate. The SME Assist hub is designed to help small and medium enterprises, and R&D groups developing new medicines and medical devices (including apps) understand their regulatory and legislative obligations with targeted tools and content.

Choose the statement below that best matches your experience.


I'm a start-up, small business, researcher developing a new product or similar enterprise. I've never interacted with the TGA before and I need to know the basics.


Articles to help you understand what your therapeutic good is, what your obligations are, how the TGA regulates and where you can go for help.

Interactive tools

Interactive tools designed to help businesses who are new to therapeutic goods regulation.

Mailing list

Subscribe to the SME Assist email list to stay up to date with latest SME information from the TGA.

Educational material

Training sessions

Discover training opportunities for small and medium enterprise, offered by TGA and external organisations.




The links below will take you directly to materials intended for a more advanced audience. These include forms, targeted guidance and the TGA's eBS portal.

Standards, guidelines and publications:

Frequently-accessed links



Phone: 1800 020 653