An AusPAR provides information about the evaluation of a prescription medicine and the considerations that led the TGA to approve or not approve an application.

Before a prescription medicine can be made available in Australia, the company legally responsible for supplying the product must lodge a submission with the TGA. The TGA then evaluates the safety, quality and effectiveness of the product to determine if the benefits to people taking the medicine outweigh the risks.

If a company wants to change something about the medicine once it is available, they also need to lodge a submission for the TGA to evaluate.

Please be aware that the AusPAR contains the Product Information for that prescription medicine at the time the TGA evaluated it. Product Information may have been updated since the AusPAR was prepared. For the current Product Information for a medicine please see: Product Information (PI).

New AusPAR format, July 2013

The format of AusPARs has been updated to give a clearer focus on the outcomes of the TGA's evaluation process and the rationale on which a decision to accept or reject an application is made.

An Extract from the full Clinical Evaluation Report is now included as an Attachment to the AusPAR. The Extract contains the information that was previously included in the body of the AusPAR itself, which now includes only the clinical evaluator's summaries of pharmacokinetics, pharmacodynamics, efficacy and safety, as well as the first and second round benefit-risk assessments.

This change has not altered the overall content of the AusPAR.

More information about AusPARs

• AusPARs: Questions & answers
  An AusPAR summarises the steps in the evaluation process that led the TGA to approve or not approve a prescription medicine submission
• Australian Public Assessment Report (AusPAR) guidance
  Information about the structure, and processes for the compilation, review and publishing of an AusPAR