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Cost recovery implementation statement

2019-2020

21 June 2019

Book pagination

The cost recovery implementation statement outlines the TGA's regulatory costs and provides detailed information on TGA's cost recovery arrangements.

The CRIS has been updated to reflect the revised fees and charges which were approved by the Executive Council on 21 March 2019, commencing from 1 July 2019.

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Contents

  • Introduction
    • Purpose of the Cost Recovery Implementation Statement
    • Description of the activity
      • Outcome 5: Regulation, Safety and Protection
      • Risk management approach
    • Industry groups
  • Policy and statutory authority to cost recover
  • Cost recovery model
    • A: Pre-market regulatory activities for therapeutic goods
      • 1. Prescription medicines
      • 2. Over the counter medicines
      • 3. Complementary medicines
      • 4. Medical devices
      • 5. Other therapeutic goods listed and registered on the ARTG
      • 6. Biologicals
      • 7. Blood and blood components
    • B: Compliance, monitoring and enforcement
      • Risk-based approach to regulation
      • Approach to monitoring
      • Approach to compliance
      • Prioritisation of compliance and enforcement matters
      • Other agencies
      • Advertising review
    • C: Regulation of manufacturers of therapeutic goods
      • Good manufacturing practices
    • D: Access to unapproved products
      • Patient access to unapproved therapeutic goods
  • Design of cost recovery charges
    • Costs of TGA activities
      • Fees and charges
    • Fee-free regulatory activities
      • a) Patient access to unproved therapeutic goods via the SAS and AP schemes
      • b) The orphan drug program
    • ANAO audit on Application of Cost Recovery Principles
    • Regulatory reforms: Review of medicines and medical devices regulation
      • Priority registration of certain medicines
      • Risk based approach for certain minor variations to registered medicines
      • Review of low risk products
      • Application fee for Class I medical devices
    • 2019–20 Fees and Annual Charges – effective 1 July 2019 31
      • A. Lowering the application fee for export only IVD medical devices
      • B. Listed Assessed Medicines Variations Fee
      • C. Indexation increase for 2019-20
      • D. Fees and charges for Good Manufacturing Practice
  • Stakeholder consultation
  • Stakeholder engagement strategy
  • Consultation on 2019-20 fees and charges
  • Financial and non-financial performance
    • a) Financial performance
    • b) Non- financial performance
    • Risk assessment
  • Key forward events
  • CRIS approval and change register
  • Appendix 1 - Financial performance by industry sector group
    • 1. Prescription medicines
    • 2. Over the counter medicines
    • 3. Complementary medicines
    • 4. Medical devices, including in-vitro diagnostic (IVD) devices
    • 5. Good manufacturing practices
    • 6. Blood, blood components and biologicals
    • 7. Other activities (such as laboratory, medicines and chemical scheduling etc.)
  • Appendix 2 - Schedule of fees and charges
  • Appendix 3 - Annual Performance Statistics 49

Book pagination