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Regulation of biologicals (human cell and tissue therapy products), February 2011

Cost recovery impact statement

23 June 2011

The new Biological framework commenced on 31 May 2011. As the TGA recovers the full cost of its regulatory activities there will be regulatory costs for sponsors and manufacturers of Biologicals. The introduction of a comprehensive model for the regulation of all Biological gives rise to a significant change to the TGA's existing cost recovery arrangements. Accordingly, a Cost Recovery Impact Statement has been prepared in accordance with Australian Government Cost Recovery Guidelines July 2005.

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Contents

  1. Overview
  2. Australian Government cost recovery policy and guidelines underpinning biological cost recovery arrangements
  3. Design and implementation
  4. Costs to be included in charges
  5. Ongoing monitoring
  6. Periodic review
  7. Certification
  • Attachment A – HCT facilities in Australia as at December 2008
  • Attachment B – Glossary of terms