Cost Recovery Implementation Statement, 2024-2025

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