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The TGA is required to recover its costs through fees and charges for all activities that fall within the scope of the Therapeutic Goods Act 1989, including the TGA's public health responsibilities.
- A fee is charged for a service, such as a product evaluation. Fees are listed in Schedule 9 and 9A of the Therapeutic Goods Regulations 1990 and Schedule 5 of the Therapeutic Goods (Medical Devices) Regulations 2002.
- 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. A list of charges can be found in the Therapeutic Goods (Charges) Regulations 1990.
Each year we consult with industry representative bodies in relation to proposed changes to fees and charges and publish a Cost Recovery Implementation Statement (CRIS).
The CRIS provides information on how the TGA implements cost recovery activities associated with the registration and listing of medicines and inclusion of medical devices, including IVD devices, and biologicals onto the ARTG and the ongoing monitoring and surveillance of them.