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Australian Public Assessment Report (AusPAR) guidance document
Version 1.5, March 2015
Principles to be applied for the deletion of commercially confidential information and personal information in an AusPAR
Content for an AusPAR is derived from various outputs of the assessment and decision-making processes. Given that 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.
This document provides general principles to confirm the approach by TGA to the identification and treatment of CCI and personal information in the drafting of the AusPAR. While the sponsor is afforded the opportunity to review the draft AusPAR, the TGA expects the sponsor to only raise concerns about AusPAR content from a CCI or personal information perspective, if it believes there is a justification for an exception to the general principles provided in this guide.
This guide and the approach of the TGA reflect compliance with the considerations that give rise to the commercial exemptions in the Freedom of Information Act 1982 and relevant privacy principles.
Openness and transparency of the regulatory process is important in the promotion of public health. However, unless there is an overriding public interest in disclosure, the TGA will refrain from disclosing CCI or personal information.
2 General principles - commercially confidential information (CCI)
The TGA's approach to the release of information is set out in the TGA Approach to disclosure of commercial in confidence information (CCI).
'Commercially confidential information' means any information which:
- is not in the public domain or legally publicly available; and
- where disclosure may undermine or prejudice the economic interest or competitive interests of the owner of the information.
These principles will be applied so that CCI can be deleted prior to publication of an AusPAR.
It should be noted that CCI is not determined by a sponsor marking information as CCI when provided to the TGA as part of a submission dossier or otherwise as part of the assessment or related process. In all instances the above definition will apply.
Information that is already in the public domain, or comes into the public domain prior to the publication of the AusPAR, is not considered commercially confidential. This includes published references or compiled searches for information submitted in support of an application to register a prescription medicine.5 If information has been in the public domain through a breach of the law, it could still be considered confidential in accordance with the principles of this document. However, the onus is on an owner of the information to inform the TGA (in writing) of the breach.
For the purposes of AusPARs, the TGA has adopted the EMA approach which broadly defines the following two categories of information considered CCI:
- confidential intellectual property, "know-how" and trade secrets (including for example formulas, programs, process or information contained or embodied in a product, unpublished aspects of trademarks, patents etc.); and
- commercial confidences (e.g. details of commercial arrangements, development plans of a company).
3 Information on the quality and manufacturing of medicines
In general, detailed information in relation to the matters described below may be CCI but more general information should be disclosed. It may be however that in certain circumstances, even a general description of a specific aspect could be regarded as CCI, if justified.
4 Composition and product development
In general, pharmaceutical development information for new products is CCI. This includes detailed data concerning active substances, formulation and manufacturing and test procedures and validation.
In general, the names of manufacturers or suppliers of the active substance or the excipients are CCI unless disclosure is necessary for public health reasons (e.g. for some biological products).
The final qualitative formulation (composition) of the authorised product is not CCI.
5 Active substances
The principles contained in the diagram (Figure 3) apply to pharmaceutical and biological products and also to novel excipients.
Figure 3. Classification of commercially confidential information for active substances
6 Finished product
The principles contained in the diagram (Figure 4) apply to pharmaceutical and biological products. Any confidentiality issue regarding novel packaging or medical device aspects should be justified by the sponsor and will be assessed according to the below principles.
Figure 4. Classification of commercially confidential information for finished product
7 Nonclinical and clinical information
As a general rule, information encompassing nonclinical and clinical development and its subsequent assessment by TGA is not CCI, examples include:
- data generated by the sponsor using another sponsor's product, e.g. comparative studies against the reference medicinal product are not CCI by virtue of this is fact only. However the commercial confidentiality of such data shall be assessed in accordance with the principles set out in this document
- published references submitted in support of an application to register a prescription medicine are also not CCI
- information related to environmental risk assessments and risk management plans.
Examples of CCI include:
- specific details on a method used in a study, which, upon justification from the sponsor, could be regarded as trade secret
- development plan from the company, e.g. for a different indication, when it is neither requested by TGA nor related to the safety of the product would also be CCI.
However, when such studies, their results and their timelines are part of the conditions for ARTG approval, they are not regarded as CCI.
8 Information on inspections
Information on the outcome of inspections is not CCI, however specific a detail regarding facilities and equipment is considered to be CCI.
9 Contractual agreements
Contractual agreements between individuals or organisations are generally considered CCI. Where contracts exist between companies and contract research organisations that have contributed to or are responsible for important information included in the dossier, they are generally not CCI.
10 Scientific advice
All information about new developments and formulations are CCI.
11 Pharmacovigilance information
Generally, a quantitative description of the sponsor's proposed pharmacovigilance activities is not considered to be CCI. However, detailed descriptions of the pharmacovigilance system can at times be considered confidential if they contain individual patient data or business strategies such as planned studies or commercial agreements involving other companies or organisations.
12 List of references and original manuscripts
The list of references of the publications included in the dossier, or subsequent assessment processes is not CCI. An exception is if the actual manuscripts are included and they are subject to copyright.
13 Personal information
"Personal information" refers to information or an opinion about an identified individual, or an individual who is reasonably identifiable:
- whether the information or opinion is true or not; and
- whether the information or opinion is recorded in a material form or not.6
Personal information is not normally included in an AusPAR.
- See also material at Section 4.3.4 - For literature based submissions.
- See definition in subsection 6(1) of the Privacy Act 1988.