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This Cost Recovery Implementation Statement (CRIS) provides information on how the Therapeutic Goods Administration (TGA), within the Department of Health, implements and cost recovers its regulatory activities. The TGA's regulatory activities are associated with the registration and listing of medicines and inclusion of medical devices, including in vitro diagnostic (IVD) devices, and biologicals onto the Australian Register of Therapeutic Goods (ARTG) and the ongoing monitoring and surveillance of them.
Contents
- Introduction
- Policy and statutory authority to cost recover
- Cost recovery model
- Design of cost recovery charges
- Stakeholder consultation
- Consultation on the 2022-23 fees and charges
- Financial and non-financial performance
- Key forward events
- CRIS approval and change register
- Appendix 1 - Financial performance by industry sector group