Therapeutic goods regulation 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 therapeutic goods regulation understand their regulatory and legislative obligations.

How we can help

• Regulation essentials
  A general overview of the regulatory processes you need to be aware of if you are a sponsor of a therapeutic good in Australia.
• Workshops and events
  SME Assist holds regular events including workshops, such as the 'Meeting Your Obligations' workshop, and webinars, which provide information about therapeutic goods regulation.
• SME guidance material
  • Overview of applying for market authorisation
  • Understanding ingredient requirements
  • Overview of medical device and IVD regulation
  • Researcher considerations
• Educational videos
  Educational videos on various topics to help you understand therapeutic goods regulation in Australia.
• Interactive decision tools
  Online tools designed to assist you understand our regulatory requirements and meet your obligations.
• Case studies
  These case studies provide practical examples of what you may come across and show some of our guidance, legislation and policy in action.
• Useful resources for business
  Additional information you may require during the product lifecycle.
• Subscribe to SME Assist
  Stay up-to-date with the latest SME Assist information including upcoming workshops, webinars and guidance articles by subscribing to our mailing list.

Contact SME Assist

SME Assist is here to help with general questions you have about therapeutic goods regulation.