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Australian Public Assessment Reports for prescription medicines (AusPARs)

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Date Active Ingredient Product Name
15 Nov Brexpiprazole Rexulti
13 Nov Alirocumab Praluent
12 Nov Fosfomycin trometamol Monurol
8 Nov Pegaspargase Oncaspar
24 Oct Leuprorelin Eligard
17 Oct Etanercept Erelzi
15 November 2018

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.

Before a prescription medicine can be made available in Australia, the company legally responsible for supplying the product must lodge a submission with the TGA. The TGA then evaluates the safety, quality and effectiveness of the product to determine if the benefits to people taking the medicine outweigh the risks.

If a company wants to change something about the medicine once it is available, they also need to lodge a submission for the TGA to evaluate.

Please be aware that the AusPAR contains the version of the Product Information for that prescription medicine which was approved with the submission which the AusPAR describes. Product Information may have been updated since the AusPAR was prepared. For the current Product Information for a medicine please see: Product Information (PI).

TGA is reviewing the operation of transparency measures and are considering activities to increase transparency of medicines approvals and the decision making process behind these. As part of these reforms we aim to facilitate more rapid publication of the regulatory decision process. To this end, TGA will phase out publication of the Extract from the Clinical Evaluation Report for Australian Public Assessment Reports (AusPARs).

The AusPAR document includes a summary of the clinical findings, while the Extract from the Clinical Evaluation Report provides more detail about the clinical assessment. There are no changes to the AusPAR document which means that the summary of the clinical findings will continue to be available.

This means that from 17 September 2018:

  • Sponsors of AusPAR eligible prescription medicine submissions will soon begin receiving only one document - the AusPAR document - to review; AND
  • AusPARs will soon be published with only one attachment, the Product Information (PI) that was approved with the submission described in the AusPAR.

In the next few months, as we transition to the new arrangements, some AusPARs may still include the Extract from the Clinical Evaluation Report. However, we anticipate that by the end of 2018, all newly published AusPARs will only have the PI as an attachment.

This initiative is subject to ongoing assessment. We will work closely with stakeholders to review our AusPAR publication processes including advancing other transparency activities.

For questions and further assistance, email us at auspars@health.gov.au.

The content of AusPARs will be updated to provide increased transparency of TGA's evaluation process through the inclusion of a registration timeline in each AusPAR. The registration timeline will be included in AusPARs published after 1 January 2018.

The registration timeline outlines the designation (if applicable) and major evaluation steps through which the sponsor's application passed on the way to TGA's registration decision. This timeline includes dates outlining TGA's evaluation commencement and completion, risk-benefit assessment, and the advisory committee meeting (if applicable). The registration timeline also includes the number of TGA working days from the acceptance of the submission to TGA's decision.

These dates represent a more comprehensive list of evaluation events than previously published in AusPARs, which included only the registration decision date and, for approved submissions, the date of entry onto the ARTG.

This change has been made in the interests of providing more information about the timeliness of registration decisions, and will provide AusPAR readers with an increased awareness of the steps in TGA's regulatory process.

AusPAR paper co-authored with EMA in Drug Discovery Today, November 2016

Co-authoring with the European Medicines Agency (EMA), TGA published a peer-reviewed, open access review article on transparency in medicines regulation, including AusPARs and EPARs.

The article followed collaboration between two established medicines regulators who reflected on their experiences and future roles in communicating medicines information.

The paper can be freely viewed at: Transparency in drug regulation: public assessment reports in Europe and Australia Drug Discovery Today, 21(11): 1806-1813 (2016).

AusPAR format, July 2013

The format of AusPARs was updated to give a clearer focus on the outcomes of the TGA's evaluation process and the rationale on which a decision to accept or reject an application is made.

An Extract from the full Clinical Evaluation Report is now included as an Attachment to the AusPAR. The Extract contains the information that was previously included in the body of the AusPAR itself, which now includes only the clinical evaluator's summaries of pharmacokinetics, pharmacodynamics, efficacy and safety, as well as the first and second round benefit-risk assessments.

This change has not altered the overall content of the AusPAR.