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Australian Public Assessment Report (AusPAR) guidance

For prescription medicines

7 July 2021

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About this guidance

This guidance describes the information included in an Australian Public Assessment Report (AusPAR) and the circumstances under which the Therapeutic Goods Administration (TGA) publishes them.

Australian Public Assessment Reports (AusPARs)

The TGA evaluates submissions for the registration of prescription medicines in the Australian Register of Therapeutic Goods (ARTG). An AusPAR provides information on the steps undertaken in the submission evaluation, the outcomes of each step and the reasons for any decisions.

AusPARs are prepared by the TGA and published on the TGA website (under Section 61 of the Therapeutic Goods Act 1989). The publication of an AusPAR is an important part of the transparency of the TGA’s decision-making process.

Each AusPAR is a static document that provides evaluation information related to a submission at a particular point in time. The AusPAR will not be updated to reflect variations to a prescription medicine after it has been registered. A separate new AusPAR will be published for certain subsequent applications.

The first AusPAR was published in November 2009.

Under section 61 of the Therapeutic Goods Act 1989, the TGA can publish information about therapeutic goods. The following provisions are relevant:

  • subsection 61(5A), which provides that the Secretary of the Department of Health can release to the public 'therapeutic goods information' relating to any decision or action taken under the Act or the regulations made under the Act
  • subsection 61(5C), which provides that the Secretary can release to the public 'therapeutic goods information' of a kind specified under subsection 61(5D)
  • subsection 61(5D), which provides that the Minister for Health can, by legislative instrument, specify kinds of therapeutic goods information for the purpose of subsection 61(5C).

When an AusPAR is required

Not all prescription medicine applications require an AusPAR. AusPARs are published for applications where the significance to the public is considered to be high.

AusPARs by application type

The following table sets out the business rules we apply to ensure a consistent approach to AusPAR development by application type.

Other than in relation to Type A and Type B applications, the TGA will exercise discretion as to whether an AusPAR is published. For example, submissions that are taken to the Advisory Committee on Medicines (ACM) or Advisory Committee on Vaccines (ACV) are likely to get an AusPAR.

Table 1. Summary of AusPAR required by application category and types
Application categories and types AusPAR
Category 1 and 2 applications
Type A New chemical or biological entity yes
Type A New salt/ester of previously approved active ingredients yes
Type A Biosimilar medicine yes
Type B New combination of previously approved active ingredients yes
Type C Extension of indications TGA discretion
Type D Generic medicines TGA discretion
Type E Major Variation - Additional trade name no
Type F Major Variation - New medicinal product strength TGA discretion
Type F Major Variation - New dosage form TGA discretion
Type F Major Variation - New route of administration TGA discretion
Type F Major Variation - Change/increase in patient group TGA discretion
Type F Major Variation -Change in dosage TGA discretion
Type J Change to ARTG entry - Change to Product Information requiring the evaluation of clinical, non-clinical or bioequivalence data no
Category 3 applications
Type G Minor Variation - Change of formulation (excipients) no
Type G Minor Variation -Change in trade name no
Type G Minor Variation -change of container no
Type H Change to ARTG entry - minor editorial change to Product Information NOT requiring evaluation no

AusPARs for medicines assessed under non-standard pathways

AusPARs may also be developed for evaluations of medicines assessed under the following pathways for relevant application types:

AusPARs for approved, rejected and withdrawn submissions

For the relevant application types, an AusPAR will be published whether the submission is approved, rejected or withdrawn after a specific stage in the registration process. AusPARs will also be published for relevant application types where a reconsideration of the initial decision is requested, through a section 60 review or appeal to the Australian Appeals Tribunal (AAT).

Approved submissions

Where approval is granted for a prescription medicine to be supplied in Australia, we will aim to publish the AusPAR within 12 weeks from the date the approved product is included in the ARTG. This period includes the 7 day sponsor review period of the draft AusPAR. An AusPAR will be published whether or not all proposals in a submission are approved.

Where a request for a section 60 review of the TGA decision to approve or partially approve an application is made by a sponsor, the AusPAR will not be withheld from publication pending the outcome. At the conclusion of the section 60 review the published AusPAR will be updated to include information about the outcome.

Rejected submissions

An AusPAR will be published for a submission that has been wholly rejected by the TGA. It will have a similar format to that of an approved application of the same submission type.

However, publication of the AusPAR will be withheld until the end of the 90-day appeal period for a section 60 review of the TGA decision and finalisation of any such review.

If no request for section 60 review is made within the 90 days the AusPAR will be sent out for sponsor review and published as soon as practicable.

Where a section 60 review is undertaken, a summary of the outcomes will be included in the AusPAR before it is forwarded to the sponsor in accordance with the sponsor review process. For this purpose, publication of the AusPAR will follow the same process as for an approved submission.

Withdrawn submissions

Applicants can withdraw their submission for registration of a therapeutic good at any time before a decision is made by the TGA. We will publish an AusPAR for the withdrawn submission depending on when the withdrawal letter is received from the applicant sponsor, as outlined in the table below.

AusPAR publication indicators where a submission is withdrawn
Time of withdrawal AusPAR required?
Submission withdrawn before acceptance of the submission by the TGA No

Withdrawal letter is received by the TGA after acceptance but:

  • where any part of the submission is reviewed by the Advisory Committee* - before any response (or the due date) to the Request for Advisory Committee advice is received by the TGA from the applicant
  • where the submission is not reviewed by the Advisory Committee - before the end of the 14 day period for evaluation report review by the applicant, typically referred to as the review of the round 2 evaluation reports
No

Withdrawal letter is received by the TGA at any time after:

  • where any part of the submission is reviewed by the Advisory Committee* - after the applicant's Pre-Advisory Committee response to the Request for the Advisory Committee review is received by the TGA or if the due date for this request passes
  • where the submission is not reviewed by the Advisory Committee - the end of the 14 day period for evaluation report review by the applicant sponsor
Yes

* The 'Advisory Committee' refers to either the Advisory Committee on Medicines (ACM) or Advisory Committee on Vaccines (ACV), depending on the nature of the medicine.

Review by the Administrative Appeals Tribunal (AAT)

If following a section 60 review of a TGA decision, the sponsor subsequently seeks a review by the Administrative Appeals Tribunal of the decision of the Health Minister, the AusPAR will not normally be withheld from publication.

However, an appropriate notation will be made on the AusPAR indicating that the section 60 appeal decision is under AAT review.

Following the outcome of the AAT review, the AusPAR will be updated to indicate the outcome only. The AusPAR will not include an explanation of, or reasons for AAT decisions as these decisions are not made under the Therapeutic Goods Act.1989.

Typical components

An AusPAR is divided into 3 sections:

  1. Introduction to product submission
    • submission details, product background, regulatory status, Product Information
  2. Registration timeline
    • details the major milestones in the product’s application and registration process
  3. Submission overview and risk/benefit assessment
    • quality findings, nonclinical findings, clinical findings, risk management plan, risk-benefit analysis, outcome

AusPARs for approved submissions also have one or more attachments:

  • the Product Information (PI) document/s approved with the submission described in the AusPAR.

Product Information (PI) document/s approved with the submission described in the AusPAR.

Information sources

The information sources used in an AusPAR include the application details, approved Product Information (PI), ARTG entry, evaluation reports, Delegate’s Overview and Advisory Committee advice.

Commercially confidential information and personal information

As the AusPAR is a publicly available document, it is essential that any commercially confidential information (CCI) and personal information be identified and where appropriate removed prior to publication.

How we identify and treat CCI and personal information

Information on how we identify and treat CCI and personal information when drafting an AusPAR is available at Guidance for the deletion of commercially confidential and personal information in an AusPAR.

Sponsors have 7 calendar days to undertake a review of the draft AusPAR and identify any information considered to be CCI or personal information. More information on the review process for a draft AusPAR is available in sponsor review.

Literature based submissions

Applications to register a prescription medicine can under some circumstances be literature-based submissions (LBS) or partially literature-based ('hybrid' applications).

AusPARs for literature based submissions may contain a range of published literature references submitted by the sponsor. As published literature is already in the public domain, they are not considered to be CCI. The published information is considered to form part of the drug development and the TGA’s decision, and there is a public interest in making this information available.

Details relating to the literature search strategy and analysis are not published in AusPARs as these could be considered confidential intellectual property.

Sponsors have 7 calendar days to undertake a review of the draft AusPAR and identify any information considered to be CCI or personal information. If the review identifies significant issues that require resolution, the TGA will provide the sponsor with an additional 3 to 7 calendar days to review the TGA response. Sponsors must justify any claims that information is CCI or personal information which they seek to be excluded from an AusPAR. Sponsors are required to carefully consider the definitions of CCI and personal information in crafting their justification. It is not possible however, for the comments and conclusions of evaluators, the Delegate or the Advisory Committees to be edited because they are an integral part of the evaluation and decision process.

Outcome of sponsor review of a draft AusPAR

Following a sponsor's review of a draft AusPAR, the TGA will review any proposed changes relating to the removal of CCI by a sponsor.

Where there are significant disagreements about the proposed removal of CCI content, we will apply an internal review process. The sponsor will be asked to provide a request/justification in writing for the removal of the content which will be referred internally for advice (as needed) prior to a final decision being made.

The internal review process is undertaken with the aim of publishing the completed AusPAR within 12 weeks from the date the product is included on the ARTG (for approved submissions).

For more information on publishing timeframes see AusPARs for approved, rejected and withdrawn submissions.

Failure to respond within AusPAR review period

If there is no response from a sponsor to a TGA request to review a draft AusPAR, the TGA reserves the right to publish the finalised AusPAR without further reference to the sponsor.

Quality assurance

Following sponsor review, and prior to publication, the AusPAR is further reviewed by TGA Quality Assurance (QA) to ensure a consistent standard and level of quality of AusPARs. This process has been in place since 2009, when AusPAR production began. Any major changes to the AusPAR that occur during the QA process are communicated to the sponsor via email prior to publication. Minor changes will not be communicated to the sponsor prior to publication.

Publically available information

Searching AusPARs

AusPARs published on the TGA website are searchable by:

  • active ingredient
  • product name
  • sponsor.

Product Information (PI)

A copy of the PI approved with the submission is included as an attachment to the AusPAR document when it is published by the TGA. This version of the PI will remain static (similar to the AusPAR) and will be 'watermarked' to ensure that this is clear to the reader that any later version of the approved PI is available via the TGA eBusiness Services system.

Publishing the approved PI with the AusPAR does not replace the requirement for the sponsor to load their PI, and Consumer Medicine Information (CMI) documents onto the TGA eBusiness Services system.

Release of AusPAR to NPS MedicineWise

The Therapeutic Goods Information (Sharing of Information about Prescription Medicines) Specification 2015 allows the TGA to provide information from an AusPAR to NPS MedicineWise prior to its publication on the TGA website. This is to assist with the preparation of comments on newly registered medicines for publication in the Australian Prescriber.

We will only provide this information after the review process with the sponsor has been completed.

Extracts from the AusPAR will not be published in Australian Prescriber before the AusPAR is published on the TGA website.

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