Cost Recovery Implementation Statement, 2026-2027

This Cost Recovery Implementation Statement (CRIS) provides information on how the Therapeutic Goods Administration (TGA), within the Department of Health, Disability and Ageing (Department), implements cost recovery arrangements for its regulatory activities. The TGA’s regulatory responsibilities include activities related to registering and listing medicines, as well as including medical devices (including in vitro diagnostic (IVD) devices) and biologicals in the Australian Register of Therapeutic Goods (ARTG). It also licences domestic manufacturers of therapeutic goods and oversees the ongoing monitoring and surveillance of these products to ensure their safety and efficacy.

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
• Financial and non-financial performance
• Key forward events
• CRIS approval and change register