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.
Foundation
I haven’t interacted with TGA before or I need to know the basics.
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 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 ask you a series of questions about your product to help you understand your next steps.
SME Assist workshops and events where TGA specialists can help you to understand therapeutic goods regulation and your legislative responsibilities.
Advanced
I regularly interact with TGA and understand how regulation works. I know what I need to find.
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.
Email: sme.assist@tga.gov.au
Phone: 1800 020 653
The Therapeutic Goods Administration is part of the Health Products Regulation Group