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Prescription medicines business process reform project
An Australian Public Assessment Record (AusPAR) provides information about the evaluation of a prescription medicine and the considerations that led the TGA to approve or not approve a prescription medicine submission. AusPARs are prepared and published by the TGA.
An AusPAR is prepared for submissions that relate to new chemical entities, generic medicines, major variations, and extensions of indications.
Prior to publishing the AusPAR, the TGA provides the sponsor with an opportunity to review the AusPAR (allowing 14 calendar days) with the purpose of ensuring the document does not contain commercially confidential information.
AusPARs have begun being published by the TGA and are available at: Australian Public Assessment Report (AusPAR) for prescription medicines
- 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
This document is an example AusPAR document developed with the assistance of Amgen Australia Pty Ltd. The TGA would like to thank Amgen for reviewing this document and ensuring that the content does not contain information that is commercially confidential. The TGA appreciates Amgen's support in allowing the information to be published as an example of an AusPAR.
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