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We have developed decision tools to help you understand our regulatory requirements and meet your obligations.
It is important to note that the outcome of each decision tool is a guide only and based on the answers you provide throughout the tool.
Is my product a therapeutic good?
To help identify if your product is a therapeutic good, and if so, the type of therapeutic good it is likely to be.
Is my product a medical device?
To assist you in determining if your product is a medical device and should be included in the Australia Register of Therapeutic Goods (ARTG).
What classification is my medical device?
To assist you in determining the classification of your medical device (not including In Vitro Diagnostic devices).
What do I require to have a listed medicine in the ARTG?
To help you understand what is required to have your listed medicine (AUST L) included in the Australian Register of Therapeutic Goods (ARTG).
Which clinical trial scheme should I choose?
To help you determine what scheme is most appropriate for your clinical trial.
What type of GMP application do I require?
To assist you in determining if GMP licensing or certification is required.
Can I advertise this therapeutic good to the public?
To help you understand whether you can advertise a particular therapeutic good to the public.
Mandatory information required in advertising for therapeutic goods
To help you identify what information you must include when advertising therapeutic goods to the public in order for the advertising to comply with the Therapeutic Goods Advertising Code (No.2) 2018 (the Code).
Is my sports supplement a therapeutic good?
To help you determine if your sports supplement is declared to be a therapeutic good.
Pathways for complementary medicine products tool
This tool will assist potential sponsors of complementary medicines to determine the most suitable pathway to enter their product in the Australian Register of Therapeutic Goods (ARTG)
Accessing unapproved therapeutic goods tool
To help health practitioners determine which of these pathways, if any, is appropriate to be used in any given circumstance, we have developed a tool to guide you down the appropriate access pathway.
Food-Medicine Interface Guidance Tool (FMIGT)
Manufacturers and importers of products need to know whether the products are regulated as therapeutic goods or as food because different regulatory requirements apply. Consumers may also want to check if the products they are using are classified and regulated suitably.
What is the patient impact of my medicine shortage and do I have to report it to the TGA?
This online tool is to help sponsors of medicines determine the patient impact level of a shortage (or an anticipated shortage) of one of their products and whether they need to report it to the TGA.
Clearance Application Assistance Tool
The GMP Clearance Application Assistance Tool (CAAT) provides assistance in determining the general evidence requirements for your GMP clearance applications
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