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Basics of therapeutic goods regulation
The amount that regulation will cost you depends on:
- whether you are a manufacturer, a sponsor, or both
- the type of therapeutic good
- the risk classification of the therapeutic good
- the amount of data you will have to collect and provide (which can be considerable)
Be aware that there will likely be business setup costs to ensure your product can meet the regulatory requirements before you apply to the TGA, and ensure ongoing compliance with the regulatory requirements.
The TGA has both fees and charges: Summary of fees and charges
- A fee is charged for a service, such as a product evaluation
- A charge is a form of tax imposed on the regulated industry and is applied annually based on a 1 July to 30 June financial year
Failing to pay your required annual charge may result in your product being removed from the ARTG.