AusPARs: Questions & answers

Related information

30 June 2015

The AusPARs: Questions and answers are currently being revised to reflect the updated AusPAR guidance published in March 2015. For current information on AusPARs please refer to the Australian Public Assessment Report (AusPAR) guidance document.

The Therapeutic Goods Administration (TGA) has increased the transparency of the prescription medicine regulatory process by the online publication of an Australian Public Assessment Report (AusPAR).

More detailed information about AusPARs, including structure, processes for the compilation, review & publishing of an AusPAR, is available from: Australian Public Assessment Report (AusPAR) guidance.

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What is an AusPAR?

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 Product Information for that prescription medicine at the time the TGA evaluated it. Product Information may have been updated since the AusPAR was prepared. For the current Product Information for a medicine please see: Product Information (PI).

Preparing AusPARs

The TGA is responsible for developing an AusPAR. The TGA will also coordinate the review process, and facilitate publishing in line with the terms outlined in the document Australian Public Assessment Report (AusPAR) guidance.

An AusPAR is compiled by the TGA after the delegate has made a decision relating to a submission for new prescription medicines and major changes to existing prescription medicines. The draft AusPAR is forwarded to the sponsor so that they have the opportunity to identify content that is considered commercially confidential.

An AusPAR will be prepared for a product irrespective of a sponsor's current or future marketing plan.

Even if the same dossier has been submitted in both Europe and Australia, the AusPAR is designed to reflect the evaluation process undertaken by the TGA and therefore an EPAR cannot be substituted.

Format & content of AusPARs

AusPARs are compiled using information that is prepared as part of the TGA's evaluation and decision making process. This may be supplemented by information from expert advisory groups that provide independent input.

The structure and content of each AusPAR will depend on a range of factors, such as the product type, evaluation process followed, referral, or not, to an expert advisory committee and substance type.

Generally, an AusPAR will incorporate:

  • assessment summaries for each evaluation stream, comprising
    • quality
    • safety
    • efficacy
  • pharmacovigilance requirements
  • the conclusion/risk benefits which are based on the delegate overview and expert advisory groups.

The structure and content of an AusPAR for a new generic medicine will be provided in the following format:

  • Extract of the decision letter
  • Statement of bioequivalence
  • Approved Product Information

An AusPAR will not provide a chronology of the discussions/negotiation between the sponsor and the TGA.

The AusPAR will incorporate the PI approved at the time of releasing the AusPAR. The current PI/CMI relating to the product will also be available from the TGA website.

The focus of an AusPAR is to provide transparency on the evaluative procedures and decisions pertaining to the quality, safety and efficacy of a product. Disclosure of whether a product was provided with a priority review is not considered appropriate for the following reasons:

  • The TGA considers it would be to the detriment of industry to publish details of a failed application for priority review.
  • It would be inappropriate for a sponsor to promote/market a product on the basis of a priority review being granted.

The AusPAR is designed to provide transparency about the basis on which decisions are made for prescription medicines. It is possible that opinions given by EAGAR (when it existed) may be considered as part of future decisions. This is consistent with current regulatory practice.

This may be contained in the clinical summary section of the AusPAR, as well as the conclusion/risk benefits section and PI.

An AusPAR will contain a general statement about whether risk minimisation activities are required. This will be supplemented with a table containing proposed pharmacovigilance activities and proposed risk minimisation activities for each identified safety issue.

What constitutes commercially confidential information is subject to interpretation and circumstance. Guidance is provided by the Principles to be applied for the deletion of commercially confidential information, which are in the document Australian Public Assessment Report (AusPAR) guidance.

The TGA will only publish an AusPAR after the sponsor has been provided with the opportunity to review and identify commercially confidential information. Content of the final AusPAR will not be subject to further negotiation, although a sponsor may choose to exercise its statutory rights of appeal.

Publishing AusPARS

An AusPAR is prepared for submissions that relate to new chemical and biological entities, generic medicines, major variations, and extensions of indications.

The development of AusPARS began with submissions on hand from October 2009. AusPARs will not be developed for submissions prior to this.

The TGA began publishing AusPARs in December 2009.

It takes the TGA time to prepare and publish each AusPAR.

  • For submissions that are approved: this is normally no more than one month after the TGA has registered the product on the Australian Register of Therapeutic Goods (ARTG). This allows time for the AusPAR to be prepared and the sponsor to confirm that the proposed AusPAR does not contain any commercially sensitive information.
  • For submissions that are rejected: the AusPAR can not be published until a 90 day appeal period is complete.

The AusPAR is intended to reflect the regulatory actions and decisions at a specific point in time. The AusPAR will not be updated for minor variations during the lifecycle of a product. For major changes a new AusPAR will be prepared.

Yes, although the TGA will withhold publishing the AusPAR pending the expiration of the 90-day appeal period.

This depends on when the submission is withdrawn. If the submission is withdrawn prior to the sponsor being sent the Delegate's overview, notification of the withdrawal will be published in lieu of an AusPAR.

Roles & responsibilities

On receiving a draft AusPAR, a sponsor should review the content to ensure that it contains no significant commercially confidential information. The sponsor should notify the TGA in writing of the information that they believe is commercially sensitive.

The sponsor has 14 calendar days to review the proposed AusPAR and identify any information that they feel is commercially confidential that they do not want published in an AusPAR.

If a sponsor does not respond to a request to review a draft AusPAR, the TGA will proceed to publish the AusPAR in line with Section 61 of the Therapeutic Goods Act 1989.

If the TGA agree with changes proposed by a sponsor, the sponsor is notified when the AusPAR is cleared for publishing.

If the TGA do not agree with a sponsor on the removal of commercially confidential information, an internal review process commences. The TGA will seek written notification from a sponsor for the basis on which it seeks removal of the information, before commencing an internal review process. The TGA will provide a sponsor with written notification of the result, and a copy of the updated version of the AusPAR for review.

In the first instance, the TGA will adhere to the Principles to be applied for the deletion of commercially confidential information, which are in the document Australian Public Assessment Report (AusPAR) guidance. Where the proposed content remains in dispute, an internal resolution process will be undertaken by the TGA.