Australian Public Assessment Reports for prescription medicines (AusPARs)

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Recently published

Date Active Ingredient Product Name
30 Jul Pembrolizumab (rch) Keytruda
30 Jul Lisdexamfetamine dimesilate Vyvanse
20 Jul Sarilumab (rch) Kevzara, Ilsidex
19 Jul Bosentan Tracleer
19 Jul Sebelipase alfa Kanuma
20 July 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).

AusPAR content, January 2018: registration timelines

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.

More information about AusPARs

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.