This Cost Recovery Implementation Statement (CRIS) provides information on how the Therapeutic Goods Administration (TGA), within the Department of Health and Aged Care, 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) medical devices, and biologicals in the Australian Register of Therapeutic Goods (ARTG). They also include ongoing monitoring and surveillance.
Contents
Introduction
Government policy approval and statutory authority to cost recover/ charge
Cost recovery model
Risk Assessment
Stakeholder consultation on setting of Fees and Charges
Consultation on the 2024-25 fees and charges
Financial and non-financial performance
Key forward events
CRIS approval and change register
Appendix 1 - Financial performance by industry sector group
