This document provides information about the structure, and processes for the compilation, review and publishing of an AusPAR, including guidance on the principles for determining what information is commercially confidential. Furthermore, the Therapeutic Goods Information Specification 2015 specifies therapeutic goods information that can be released to the public by the Secretary under subsection 61 (5C) of the Act and refers to various information included in an AusPAR.

For more details, go to: https://www.tga.gov.au/publication/australian-public-assessment-report-auspar-guidance-document