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. Our 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 2023-24 fees and charges
Financial and non-financial performance
Key forward events
CRIS approval and change register
Appendix 1 - Financial performance by industry sector group
