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Australian Public Assessment Report (AusPAR) guidance document

Version 1.5, March 2015

11 March 2015

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4. AusPAR business rules

4.1 AusPARs by application type

The regulatory framework for prescription medicines describes applications in accordance with the category and type groupings as set out in Table 1.

Not all prescription medicine applications require an AusPAR as in many cases the significance of the change to a medicine previously approved by the TGA is low and therefore does not warrant the development of an AusPAR to detail the regulatory decision. The approved Product Information (PI) will accurately reflect the outcome of such decisions.2

The following table sets out the business rules the TGA applies to ensure a consistent approach to the AusPAR development by application type. The TGA retains discretion to decide on certain applications and this is indicated in the table.

AusPARs will not normally be published for applications that are not considered by ACPM. Thus an AusPAR will not normally be published for a generic medicine application. Other than in relation to Type A, Type B and Type C applications, the TGA will exercise a discretion as to whether an AusPAR is published, even if an application was considered by ACPM.

Table 1. Summary of AusPAR required by application category and types
Application categories and types AusPAR
Yes No TGA discretion
Category 1 and 2 applications3
Type A New chemical or biological entity tick
Type A New salt/ester of previously approved active ingredients tick
Type A Biosimilar medicine tick
Type B New combination of previously approved active ingredients tick
Type C Extension of indications tick
Type D Generic medicines tick
Type E Major Variation - Additional trade name tick
Type F Major Variation - New medicinal product strength tick
Type F Major Variation - New dosage form tick
Type F Major Variation - New route of administration tick
Type F Major Variation - Change/increase in patient group tick
Type F Major Variation -Change in dosage tick
Type J Change to ARTG entry - Change to Product Information requiring the evaluation of clinical, non-clinical or bioequivalence data tick
Category 3 applications3
Type G Minor Variation - Change of formulation (excipients) tick
Type G Minor Variation -Change in trade name tick
Type G Minor Variation -change of container tick
Type H Change to ARTG entry - minor editorial change to Product Information NOT requiring evaluation tick

4.2 AusPARs for approved, rejected and withdrawn submissions

Where approval is given for a prescription medicine to be supplied in Australia (whether or not all proposals in the submission were approved), the TGA will aim to publish the AusPAR within 12 weeks from the date the approved product is included on the ARTG. This period includes the 14 day sponsor review period of the draft AusPAR.

An AusPAR will be published where a submission is approved in any aspect.

The mechanism by which a sponsor can seek a review of a TGA decision made under section 25 of the Act is described in the document Australian Regulatory Guidelines for Prescription Medicines. A sponsor has 90 days from notification of a decision in which to request a review of the decision by the Minister (a section 60 review). This applies to all decisions (approval and rejection decisions) made by a Delegate. The sponsor can also seek such a review of a TGA decision made under section 25AA in relation to product information.

Where a request for a section 60 review of the Delegate's decision under section 25 or 25AA is made by a sponsor, the AusPAR will not be withheld from publication pending the outcome. The Minister's delegate has 60 days to make a decision on the review.

As indicated above, the TGA will aim to publish the AusPAR within 12 weeks from the time the product was included on the ARTG. In this situation, full details of the approved aspect(s) will be published. For any aspect(s) of the submission that were not approved (for instance, an indication was not approved), only the nature of that decision will be mentioned. Where relevant, appropriate notation will be made on the AusPAR and on the TGA website indicating that the decision is under review.

At the conclusion of the section 60 review the published AusPAR will be updated to include information about the outcome (e.g. whether the initial decision was upheld or not). The sponsor will also be given an opportunity to review the updated AusPAR before publication in accordance with the sponsor consultation process (see section 5 - Sponsor consultation).

If the sponsor then seeks a review by the Administrative Appeals Tribunal (AAT) of the decision of the Minister's delegate the updated AusPAR will not normally be withheld from publication. However an appropriate notation will be made on the AusPAR and on the TGA website 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. However, as the AAT decision is not made under the Therapeutic Goods Act, the AusPAR will not include an explanation of, or reasons for, that decision. Decisions of the AAT are published at Administrative Appeals Tribunal of Australia.

4.2.1 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.

The publication of the AusPAR will however be withheld pending the expiration of the 90 day appeal period for a section 60 review 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 consultation and published as soon as practicable.

A summary of the outcome of any section 60 review will be included in the AusPAR before it is forwarded to the sponsor in accordance with the sponsor consultation process (see Section 5 - Sponsor consultation). For this purpose, publication of the AusPAR will follow the same process as for an approved submission.

If the sponsor then seeks a review by the AAT of the decision of the Minister's delegate the updated AusPAR will not normally be withheld from publication. However an appropriate notation will be made on the AusPAR and on the TGA website indicating that the section 60 decision is under AAT review.

Following the outcome of the AAT review, the AusPAR will be updated to indicate the AAT outcome. However, as the AAT decision is not made under the Therapeutic Goods Act, the AusPAR will not include an explanation of, or reasons for, that decision. Decisions of the AAT are published at Administrative Appeals Tribunal of Australia.

4.2.2 Withdrawn submissions

An applicant for registration of therapeutic goods can withdraw a submission at any time. The TGA will publish an AusPAR for the withdrawn submission depending on when the withdrawal letter is received from the sponsor as outlined below in Table 2.

Table 2. AusPAR publication indicators where a submission is withdrawn
Time of withdrawal AusPAR
Yes No
Submission withdrawn before acceptance of the submission by the TGA tick

Withdrawal letter is received by the TGA after acceptance but:

  • where any part of the submission is reviewed by ACPM - before any response to the Request for ACPM advice is received by the TGA from the applicant sponsor
  • where the submission is not reviewed by ACPM - before the end of the 14 day period for evaluation report review by the applicant sponsor
tick

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

  • where any part of the submission is reviewed by ACPM - after the applicant sponsor's Pre-ACPM response to the Request for ACPM review is received by the TGA
  • where the submission is not reviewed ACPM - the end of the 14 day period for evaluation report review by the applicant sponsor
tick

4.3 Content considerations for specific application types

4.3.1 For new chemical or biological entity

The AusPAR for a new chemical or biological entity (Type A in Table 1) will generally contain all of the sections of content listed in Figure 2 reflecting the TGA's assessment of all aspects of a new product.

4.3.2 For new indications for a registered medicine

Indications for therapeutic goods are defined in the Act as 'the specific therapeutic uses of the goods'4. The content of AusPARs for new indications (Type C in Table 1) is dependent on the complexity and range of data submitted by the sponsor to support the change in indications.

4.3.3 For major variation to a registered medicine

Examples of Type F in Table 1 (major variations to registered goods) would include an application to delete a contraindication or precaution and some changes to the clinical trials section of the product information (PI). The content of AusPARs for these submissions is dependent on the complexity and range of data submitted by the sponsor to support the major variation. The TGA will exercise a discretion as to whether an AusPAR is published for Type F applications even if the application was considered by ACPM (see Table 1).

4.3.4 For literature based submissions

Applications to register a prescription medicine can under some circumstances be 'literature-based submissions' (LBS) or partially literature-based (so called 'hybrid' applications). The content of the AusPARs for these submissions may contain published literature references submitted by the sponsor as they are not considered to be commercially confidential information because the references are already in the public domain. The published information is considered to form part of drug development and the Delegate's decision and there is a public interest in making this information available.

Details of methodology and literature search strategy, the analysis of the literature search output will however not be published in an AusPAR as these could be considered as confidential intellectual property.

See further at Section 3.3, Section 5 and Appendix 2 in relation to commercially confidential information.

4.3.5 For 'generic' biological products or similar biological medicinal products

'Generic' biological products are referred to as 'similar biological medicinal products' (SBMPs) or 'biosimilars' in recognition of the fact that due to the complexity of their molecular structure and manufacturing it is not possible to produce true generic versions (Type A in Table 1).

Unlike for small molecule drugs (where a generic manufacturer is usually required to demonstrate bioequivalence between the generic and innovator products using pharmacokinetic criteria), the sponsor of an SBMP is also required to provide data to demonstrate equivalent efficacy and safety. The AusPAR document for an SBMP will therefore reflect the difference in the number and nature of studies and evaluations that are required for an SBMP to be approved for registration compared to a true generic.

Footnotes

  1. Under the Act, the Secretary is required, when approving product information, to be satisfied that it reflects the basis on which the Secretary decided to register the medicine: subsection 25AA(1).
  2. Applications are made under section 23 of the Act (for a new entry in the ARTG) or a request made under subsection 9D(3) of the Act (for a variation to the entry of a registered prescription medicine which requires the evaluation).

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