Literature-based submissions - points to consider
August 2010
The TGA guidance on Literature Based Submissions is currently being updated.
In the interim, applicants should note that:
For submissions to register a New Chemical Entity (NCE), the TGA will not accept Literature Based Submissions* if the marketing in the other country(ies) following regulatory approval in that country has been for less than ten years, except where:
- the NCE has been designated in Australia as an Orphan Drug; or
- there is no medicine registered and available in Australia that is registered for the same, or in the view of the TGA essentially the same, indication.
* including hybrid applications comprising a mix of conventional and literature based data
The purpose of this document is to assist sponsors in compiling a literature-based submission (LBS). The information is for guidance only. Adherence to this document is not a prerequisite for a submission to be accepted or approved. However, sponsors are encouraged to follow these recommendations.
When will the TGA accept data from literature-based submissions (LBS) from sponsors of prescription medicines?
Usually LBS will only be accepted for medicines with an extensive registration history, either in Australia or overseas. The most usual reason for such submissions is for changes to the product information document (PI). Under exceptional circumstances, however, LBS may be accepted for medicines, which, although they may have been marketed in other countries for many years, are considered new chemical entities (NCE) in Australia because they have never been marketed here.
Literature-based submissions - points to consider (pdf,142kb)
Contents
- 1 Introduction
- 2 Using published literature to support applications for prescripion medicines
- 2.1 Introduction
- 2.2 LBS that include a systematic review of the literature
- 2.3 Literature Based Submissions not based on a systematic review of the literature
- 2.4 The role of pre-submission consultation
- 3 References
- Appendix-1 Definitions of study types related to the classification of levels of evidence
- Appendix-2 Some other schemata of evidence levels
- Appendix-3 Checklist for reviewers of reports of randomised controlled trials