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Australian Public Assessment Report (AusPAR) guidance document

Version 1.5, March 2015

11 March 2015

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3. AusPAR description

3.1 AusPAR structure

An AusPAR records the steps undertaken by the TGA in the evaluation of the application to register a prescription medicine, the outcomes of each step and describes the reasons for any decision on the application by the TGA.

The structure and content of an AusPAR may vary according to a range of factors such as:

  • the submission / product type - this is the matter to which the submission relates (as described in Table 1)
  • the process - the submission may have been referred to an expert advisory committee, for example the Advisory Committee on Prescription Medicines (ACPM) and/or the Pharmaceutical Subcommittee of ACPM
  • the substance type - whether the submission relates to a radiological agent, radiopharmaceutical, certain vaccines, or a range of other substances
  • the nature of the process - if the decision or other information relating to the evaluation changes as a result of a review or appeal.

The component sections of an AusPAR for submissions such as new chemical entities are described in Figure 1.

Figure 1. Typical AusPAR components

Figure 1. Typical AusPAR components

The AusPAR also has two attachments:

  • Attachment 1: The approved Product Information as at the time the AusPAR was prepared and first published.
  • Attachment 2: Extract from the clinical evaluation report containing more details of the clinical findings.

3.2 AusPAR content

Depending on the submission type, an AusPAR is compiled by the TGA using key components and stages of the evaluation and assessment process as shown in Figure 2.

Figure 2. AusPAR sources of content

Figure 2. AusPAR sources of content

3.3 Commercially confidential information and personal information

Guidance on the classification of commercially confidential information is provided at Appendix 2 - Principles to be applied for the deletion of commercially confidential information and personal information in an AusPAR.

It provides guiding principles and procedural direction to assist the TGA and a sponsor to identify what information may be considered for removal by the TGA from a draft AusPAR. See also Section 5 - Sponsor consultation.

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