You are here

SME Assist

10 October 2018

Therapeutic goods regulation and legislation can be challenging to navigate.

SME Assist is a dedicated service that TGA offers to help small to medium enterprises (SMEs), researchers, start-ups and those unfamiliar with regulation to understand their regulatory and legislative obligations.

Choose the statement below that best matches your experience.


I haven’t interacted with TGA before or I need to know the basics.

Subscribe to our mailing list

Subscribe to the SME Assist email list to stay up to date with the latest SME information from TGA, including upcoming workshops and events.

Guidance articles

Guidance articles to help you understand the basics of regulation, how TGA regulates therapeutic goods, what your obligations are, and where you can go for more help.

Interactive decision tools

Interactive decision tools ask you a series of questions about your product to help you understand your next steps.

Workshops and events

SME Assist workshops and events where TGA specialists can help you to understand therapeutic goods regulation and your legislative responsibilities.

Educational materials


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:

Common links



Phone: 1800 020 653