In Australia, clinical trials are regulated by the Therapeutic Goods Administration (TGA). New treatments that are not yet approved for use in Australia are called ‘unapproved’ therapeutic goods.
The Australian clinical trial handbook describes the processes and rules that must be followed when designing and running clinical trials of unapproved therapeutic goods.
In Australia, clinical trials must follow many national and international laws and regulations. This is to ensure they are run safely and ethically.
For more information, visit Therapeutic Goods Association: Clinical trials.