AusPARs: Questions and answers

The Therapeutic Goods Administration (TGA) provides transparency of the prescription medicines registration process via the online publication of Australian Public Assessment Reports (AusPARs). More detailed information about AusPARs is available on the TGA website, including the TGA AusPAR for prescription medicines guidance document.

Which submissions will have an AusPAR?

An AusPAR is generally prepared for submissions for products containing new chemical and biological entities, biosimilar medicines, major variations and extensions of indications where the TGA decision maker (the Delegate) received independent expert advice. In addition, an AusPAR will be published if the information is considered to be in the interest of the Australian public.

See: Table 1. Summary of AusPAR required by application category and types in the Australian Public Assessment Report (AusPAR) guidance document

Will an AusPAR be published for withdrawn submissions?

This depends on when the submission is withdrawn in terms of the stage of the registration process reached. The time the TGA was notified of the sponsor's intent to withdraw their submission is critical. If the submission is withdrawn prior to the TGA's receipt of the sponsor's response to the Delegate's overview or request for expert advice, then an AusPAR will not be published. Sponsors are notified of the required/expected response time period when they receive the Delegate's overview or request for expert advice. Generally a sponsor is given two (2) weeks to provide a response from the time of receipt of the Delegate's overview. If no response or notification of withdrawal is received in this time an AusPAR will be published.

What if the submission is rejected?

If the initial TGA delegate makes a negative decision, the TGA will withhold publishing the AusPAR pending the expiration of the 90 day appeal period for an internal review and the finalisation of any such review. A summary of the outcome of any internal review will be included in the AusPAR before it is forwarded to the sponsor as part of the routine consultation process.

If no request for an internal review is made within the 90 days, the AusPAR will be sent out for sponsor consultation and published as soon as practicable.

Will an AusPAR be published before an AAT review?

If the sponsor seeks a review of the registration decision by the Administrative Appeals Tribunal (AAT), the AusPAR will not be withheld from publication and the standard publication procedures will be followed once the TGA's regulatory processes are finalised.

Published AusPARs will be updated to incorporate the outcome of the AAT review process once it is known.

Do all registered medicines have published AusPARs?

Only prescription medicines entered on the ARTG after November 2009 or which have had a new entry to their ARTG registration since this time will have an AusPAR.

The AusPAR you are looking for may be under a different trade name (particularly if that trade name was added after the product was initially approved). Try searching using the active ingredient name for the product if you are unsuccessful searching using the trade name.

The AusPAR you are looking for may be in a preparatory stage and may not be ready for publication yet. If you wish to be notified when new AusPARs are published, you can join the AusPAR email notification list by filling out the form at: TGA AusPAR email list.

When will AusPARs be published?

The TGA aims to publish an AusPAR within 12 weeks of the new entry on the Australian Register of Therapeutic Goods (ARTG).

How are AusPARs prepared?

An AusPAR is compiled after the completion of the registration process. An AusPAR contains excerpts from key documents from the evaluation, expert advisory and decision phases of the registration process for prescription medicines. The content of an AusPAR will depend on the type of evidence required to support the submission. All relevant areas will be included in an AusPAR.

The draft AusPAR is provided to the product sponsor prior to publication to allow the sponsor an opportunity to identify content they consider to be commercially confidential.

What information is included in an AusPAR?

An AusPAR will be compiled using information that is prepared as part of the TGA's evaluation and decision making process as well as the sponsor's response to the Delegate's overview or request for expert advice. This may be supplemented by information from expert groups that provide independent advice.

The structure and content of each AusPAR will depend on a range of factors such as the submission type, registration process, expert advice referrals, and the nature of the product.

Generally, the AusPAR will incorporate the following sections:

• Assessment summaries for the relevant areas including quality and manufacturing, nonclinical, clinical and pharmacovigilance requirements.
• Conclusions based on the Delegate's overview, expert advisory group(s) advice and risk benefit analysis.
• Product sponsor's response to the Delegate's overview or request for expert advice.

An AusPAR will not provide a chronology of the discussions between the sponsor and the TGA that may occur as part of the registration process or during the preparation of the AusPAR.

Will the AusPAR include information about RMPs?

If a Risk Management Plan (RMP) was required and assessed by the TGA for the submission, the AusPAR will contain a general description of whether risk minimisation activities are required. This will be supplemented with information regarding the proposed pharmacovigilance activities and proposed risk minimisation activities for each identified safety issue. See: Australian pharmacovigilance requirements and recommendations for medicine sponsors.

What does the sponsor consultation involve?

On receiving a draft AusPAR from the TGA, a product sponsor should review the content to ensure that it does not contain commercially confidential information. The sponsor should notify the TGA in writing of the information they consider to be commercially sensitive. The sponsor should submit a detailed justification for each requested deletion of commercially sensitive material from the AusPAR and the Extract from the Clinical Evaluation Report (which is published with the AusPAR as 'Attachment 2').

The sponsor will have 14 calendar days to undertake a review of the draft AusPAR Extract from the Clinical Evaluation Report and identify any information that they consider to be commercially confidential that they do not wish to be included in the published AusPAR. If the TGA supports the amendments proposed by a sponsor, the sponsor will be notified in writing as soon as possible. The TGA will undertake an internal review of the sponsor's request to remove information they consider commercially confidential and assess the justifications provided by the sponsor. The TGA will provide a sponsor with written notification of the result and a copy of the updated version of the AusPAR for review.

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

What if the sponsor does not respond with comments

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

How is 'commercially confidential' defined?

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 TGA AusPAR for prescription medicines guidance document.

Where the proposed content remains in dispute, an internal review process will be undertaken by the TGA.

Will the AusPAR be updated during the lifecycle of a product?

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

Will the AusPAR include a copy of the latest PI?

The AusPAR will incorporate the final Product Information (PI) document(s) approved with the submission described in the AusPAR. See below for more information on products with more than one trade name.

PI documents are continually updated during the lifecycle of a product. Please note that the most up-to-date PI relating to a product is available from the TGA website at: Product Information (PI).

What if a product has more than one trade name?

Where an AusPAR is required for a submission with multiple proposed trade names for the product, the AusPAR will be published once one (1) of the trade names is added to the ARTG. If multiple trade names are approved and added to the ARTG concurrently, this will be indicated in the AusPAR and the AusPAR will be listed under each trade name on the TGA website. See: Browse AusPARs by product name.

If additional trade names are later added to the ARTG, through separate submissions additional AusPARs will only be prepared if there is also a major change to the product registration, for example if a new indication is approved.

Will changes to ingredient names affect AusPARs?

Since April 2016, the TGA has been updating some medicine ingredient names used in Australia to align with names used internationally. Under the International Harmonisation of Ingredient Names (IHIN) Project the names of ingredients used in therapeutic goods have been updated to use international nomenclature. The list of ingredients that were updated is at: Updating medicine ingredient names - list of affected ingredients.

New products must use the new ingredient names. Sponsors of existing products have been allowed a transition period of four years (until April 2020) to update the names of ingredients on labels and in Product Information (PI) and Consumer Medicine Information (CMI) documents. For more information on this project see Updating medicine ingredient names.

AusPARs describing applications submitted after April 2016 will have the new ingredient name(s). For relevant AusPARs already published on the TGA website, the TGA is in the process of adding the new ingredient name to the individual AusPAR landing page as well as to the front page of the AusPAR documents. Hence, AusPARs for submissions made before April 2016 will eventually have both the new and the old ingredient names recorded.

Can an EPAR be used instead of an AusPAR?

Even if the same dossier has been submitted in both Europe and Australia, the AusPAR is designed to reflect the evaluation and decision making processes undertaken by the TGA and therefore cannot be substituted by a European Public Assessment Report.

Will an AusPAR include information about local treatment guidelines?

Information on local treatment guidelines may be contained in the clinical summary section of the AusPAR, as well as the 'conclusion/risk benefits' section and the Product Information (PI) document.

What if the product is not locally launched or marketed?

An AusPAR will be prepared for a product that has been registered on the ARTG irrespective of a sponsor's current or future marketing plan for Australia.

Can I be notified when a new AusPAR is published?

If you wish to be notified when new AusPARs are published, you can join the AusPAR email notification list by filling out the form at: TGA AusPAR email list.

What is an AusPAR?

AusPARs are intended to provide transparency of the pre market registration process and outline the scientific rationale for the TGA's regulatory decisions. AusPARs are modelled on the European Public Assessment Reports (EPARs) issued by the European Medicines Agency. An AusPAR will also incorporate the Product Information (PI) document, if a PI was approved with that particular submission.

AusPARs are published on the TGA website at: Australian Public Assessment Reports for prescription medicines

Who prepares AusPARs?

The TGA is responsible for preparing an AusPAR in consultation with the sponsor of the registration application. The TGA coordinates the sponsor consultation process and facilitates publishing in accordance with the terms outlined in the TGA AusPAR for prescription medicines guidance document.