Australian Public Assessment Reports for prescription medicines

TGA

28 August 2019 - TGA is reviewing the operation of transparency measures and are considering activities to increase transparency of medicines approvals and the decision making process behind these. 

As part of these reforms we aim to facilitate more rapid publication of the regulatory decision process. To this end, TGA will phase in a more streamlined Australian Public Assessment Report format.

The streamlined AusPAR document is structured as follows:

  • Introduction, Registration Time Line, Delegate's Overview and ACM Resolution sections, as previously.
  • The Quality, Non-clinical, Clinical and Risk Management Plan evaluation summaries, along with the sponsor's response to the Delegate's Overview, will no longer be included.

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Michael Wonder

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Michael Wonder