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Half yearly performance snapshot: July to December 2018

1 July to 31 December 2018

2 April 2019

The TGA prepares an annual TGA Business Plan, which identifies the priority activities being undertaken over the financial year and is available on the TGA website. This Half Yearly Performance Snapshot provides statistical information for 1 July to 31 December 2018 in relation to our regulation of therapeutic goods, tracking our progress against the priorities we have identified for the year. This data will be incorporated into our Annual Performance Statistics Report for the 2018-19 financial year, to be published on the TGA website in the second half of 2019.

As part of our annual Business Plan we continue to implement the Australian Government response to the Review of Medicines and Medical Devices Regulation (MMDR) involving a significant program of work. Throughout 2018-19 we will continue to roll out reforms in a staged approach with the majority of activities set to conclude by the end of the financial year. Some longer term reforms are scheduled to commence later to allow time for transition processes to be put in place.

Half yearly performance snapshot: July to December 2018

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Contents

  • About the Therapeutic Goods Administration
  • Introduction
    • Performance highlights
    • Processing and approval times
    • 1. Prescription medicines
    • 2. Over-the-Counter medicines
    • 3. Complementary medicines
    • 4. Biologicals and blood components
    • 5. Medical devices
    • 6. Exports
    • 7. Access to unapproved therapeutic goods
    • 8. Licensing and manufacturing
    • 9. Laboratory testing
    • 10. Medicine and Vaccine Adverse Event Reporting
    • 11. Medical device incident reports
    • 12. Regulatory compliance
    • 13. Advertising complaints
    • 14. Recalls
    • 15. Pharmacovigilance Inspection Program
    • 16. Reporting of medicine shortages