You are here
Australian Public Assessment Reports for prescription medicines (AusPARs)
Information and notices about AusPARs
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. New AusPARs may be provided to reflect changes to indications or major variations to a prescription medicine subject to evaluation by the TGA.
AusPAR documents are broken into sections:
- registration timeline
- Delegate's Overview
- ACM resolution.
The AusPAR and the product information (PI) approved with the submission are published as one document. Product information may have been updated since the AusPAR was prepared.
For the current product information for a medicine, see Product information.
More information on AusPARs
- GuidanceThis guidance describes the information included in an Australian Public Assessment Report (AusPAR) and the circumstances when we publish them.
- PageThe Australian Prescription Medicine Decision Summary (AusPMDS) provides a short overview of the TGA's evaluation process leading to the registration of a new prescription medicine on the Australian Register of Therapeutic Goods (ARTG).
- GuidanceGuidance in how TGA identifies and treats commercially confidential information (CCI) and personal information in drafting an AusPARs.