Australia New Zealand
Therapeutic Products
Authority

Information last updated: October 2000
URL: http://www.anztpa.org/about/
   0010ria.htm

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Regulatory impact analysis - A single joint Australia and New Zealand therapeutics goods agency

October 2000

• Regulatory impact analysis - A single joint Australia and New Zealand therapeutics goods agency (pdf, 367kb)

In July 2000, NZIER was commissioned to prepare a regulatory impact analysis of a move to a Single Joint Agency (SJA) to regulate therapeutic goods in Australia and New Zealand. Impacts were to be measured in three separable components.

• An analysis of the costs and benefits for Australia of setting up the proposed joint agency against the status quo.
• An analysis of the costs and benefits for New Zealand of setting up the proposed joint agency against the counterfactual of operation under proposed legislation to regulate medicines, medical devices and complementary medicines/healthcare products.
• An analysis of the costs and benefits for New Zealand of setting up the proposed joint agency against the counterfactual of operation under proposed legislation to regulate medicines, medical devices and complementary medicines/healthcare products, in a way which permits unilateral recognition by New Zealand of some other countries’ certification.

Contents of document

• Executive summary
• Conclusions
• General summary
• Australia
  • Benefits
  • Costs
• New Zealand
  • Benefits
  • Costs
  • Caveats
• Overview
• Assessment of costs and benefits
• Impact on consumers, industry, and governments
  • Australia
  • New Zealand
• Impacts on trade
• Regulatory capacity
• Regional effects - therapeutic sector development and conformance

1. Introduction
   • 1.1 Background
   • 1.2 Terms of reference
   • 1.3 Deliverables
   • 1.4 Report coverage & structure
2. Approach
   • 2.1 Principles adopted
   • 2.2 Conceptual structure
   • 2.3 Assessing regulatory impacts
3. Regulatory principles
4. Therapeutics Regulation in Australia & New Zealand
   • 4.1 Overview
   • 4.2 Australian regulation
   • 4.3 New Zealand regulation
5. Administrative structures
   • 5.1 Australia
   • 5.2 Harmonisation and CER
   • 5.3 International treaties and agreements
   • 5.4 Pharmaceutical Benefits Scheme
   • 5.5 Medsafe
   • 5.6 Pharmac
6. Industries and markets
   • 6.1 Global trends
   • 6.2 Australia
   • 6.3 New Zealand
   • 6.4 External trade and relationships
7. Economic effects of Therapeutics regulation
8. 8. Economic impacts of a SJA
   • 8.1 Objective
   • 8.2 Broad analysis
9. Cost benefit assessment - Australia
   • 9.1 Australia
10. Cost benefit assessment - New Zealand
    • 10.1 The status quo, other regulatory options, the SJA
    • 10.2 Cost benefit assessment of SJA in New Zealand
11. Flow-on effects of SJA
    • 11.1 Transitional issues in forming SJA
    • 11.2 Trade and control systems
    • 11.3 Regulatory capacity
    • 11.4 Regional effects: therapeutic sector development & conformance
12. References

• Appendices
  • Appendix A: SJA - typical Regulatory Decisions
  • Appendix B: Measurement problems

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