Literature based submissions

The TGA guidance on literature based submissions has been updated.

The purpose of this guidance is to assist applicants compile a literature based submission (including mixed applications), and replaces the previous TGA guidance: Literature-Based Submissions - Points to consider (2003).

This guidance is now in three parts:

• Pre submission guidance for literature based submissions
• Dossier requirements for literature based submissions
• Systematic literature searches for literature based submissions

For Over-the-Counter (OTC) medicines, you should also refer to the:

• Australian Regulatory Guidelines for OTC Medicines (ARGOM), Safety and efficacy data, Section 4.1 Literature-based submissions
  Note: (This includes LBS pre-submission requirements for OTC medicines.)

What is a literature based submission?

These rely solely, or predominantly, on bibliographic data (i.e. based on published literature) to support the safety and efficacy claims.

For the purpose of evaluating prescription and OTC medicines (either an application to register, or an application to vary an existing registration) the TGA accepts three types of applications:

• Conventional applications - containing full study reports of company sponsored studies conducted by them (or on their behalf) that demonstrate safety and efficacy claims
• Literature based submissions - relying solely on bibliographic data to support safety and efficacy claims
• Mixed applications - Mixed applications refer to dossiers where Module 4 and/or 5 consists of a combination of complete study reports of limited nonclinical and/or clinical studies carried out by the applicant and supported with bibliographical references. The nonclinical aspects of mixed applications are further discussed in Guideline on the non-clinical documentation for mixed marketing authorisation applications CPMP/SWP/799/95.
• Mixed applications are treated in the same way as literature-based submissions.

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