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Australian Public Assessment Report (AusPAR) guidance
Commencing in December 2009, the Therapeutic Goods Administration (TGA) has begun publishing information about its decisions relating to the evaluation of prescription medicines. The information outlines the outcomes of the TGA’s evaluation process, and provides the rationale on which a decision was made to approve or not approve a prescription medicine submission. The information is provided in an Australian Public Assessment Report (AusPAR), which is published on the TGA website. The AusPAR represents a key addition to the regulatory framework for the evaluation of prescription medicines within Australia.
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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.