Australian Public Assessment Report (AusPAR) guidance

For prescription medicines

Guidance on the information that we include in AusPARS and when we publish them.

Last updated

1 November 2023

This guidance describes the information included in an Australian Public Assessment Report (AusPAR) and the circumstances when we publish them.

We evaluate submissions for the registration of therapeutic goods on the Australian Register of Therapeutic Goods (ARTG). An AusPAR provides information on the steps undertaken in the submission evaluation, the outcomes of each major evaluation and the reasons for any decisions.

We produce AusPARs and publish them on our website (under section 61 of the Therapeutic Goods Act 1989 (the Act). The publication of an AusPAR is an important part of our commitment to transparency of the decision-making process.

AusPARs are published for submissions where the significance to the public is considered to be high. They are not published for every prescription medicine submission.