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TGA presentation: Guidance on bioequivalence, 4 June 2020

9 June 2020

Disclaimer

These presentation papers are provided on the TGA's website solely for the purpose of indicating or suggesting what TGA representatives spoke about to the various conferences and seminars to which it relates. The papers are not legislative in nature and should not be taken to be statements of any law or policy in any way.

The Australian Government Department of Health (of which the TGA is a part) advises that (a) the presentation papers should not be relied upon in any way as representing a comprehensive description of regulatory requirements, and (b) cannot guarantee, and assumes no legal liability or responsibility for, the accuracy, currency or completeness of the information contained in the presentation paper.

Presentation

  • Presented by: Wenjie Ji and Dr Christopher Crane
  • Presented at: ARCS webinar online
  • Presentation date: 4 June 2020
  • Presentation summary: New bioequivalence and biowaiver data summary templates to be included in the dossier for new generic prescription medicine submissions.

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