Australian Public Assessment Reports for prescription medicines (AusPARs)

A new transparency initiative with regards to new prescription medicine decisions will take effect from 1 September 2019. An Australian Prescription Medicine Decision Summary will be published shortly after the first ARTG registration of new prescription medicines. It will be in a more consumer friendly question and answer format and will initially only be made available for new chemical or biological medicine registrations. The TGA aims to publish this summary within 10 days of ARTG registration of the new medicine.

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 in a more streamlined Australian Public Assessment Report (AusPAR) format.

The streamlined AusPAR document is structured as follows:

• Introduction, Registration Time Line, Delegate's Overview and ACM Resolution sections, as previously.
• The Quality, Nonclinical, Clinical and Risk Management Plan evaluation summaries, along with the sponsor's response to the Delegate's Overview, will no longer be included.

This means that from 1 September 2019 sponsors of AusPAR eligible prescription medicine submissions will still receive one document - the AusPAR - to review, however it will be a significantly shorter document than previously.

In the next few months, as we transition to the new arrangements, some AusPARs may still be published with the old format. However, we anticipate that by the end of 2019, all newly published AusPARs will be published with the streamlined format.

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.

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.

• 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.
• Guidance for the deletion of commercially confidential and personal information in an AusPAR
  Information about how the TGA identifies and treats commercially confidential information (CCI) and personal information in an AusPAR.
• AusPAR mailing list
  Sign up to receive an email notification every time a new AusPAR is published.
• AusPAR user survey results
  From 2 May 2016 to 31 July 2016, TGA ran a survey to receive feedback about the AusPARs for prescription medicines.

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.

The ingredient name appearing on an AusPAR is that which was accepted at the time of publication. Since 2016, some medicine ingredient names have changed to align with names used internationally. The AusPAR search function has been optimised to reflect this change. You will be able to search for an AusPAR using either the new or old ingredient name.