New and updated guidance

30 June 2015

The TGA has published a number of new and updated guidelines for applicants and sponsors.

  • General dossier requirements
    Describes the minimum basic requirements for preparing and presenting information that is submitted in support of an application, and applies to all therapeutic good types.
  • Common Technical Document (CTD) Module 1
    Provides details on what information and documents must be included in Module 1. This has been updated to align with the introduction of Australian eCTD submissions.
  • Mandatory requirements for an effective application
    Updated to align with the introduction of Australian eCTD submissions.
  • Non-eCTD electronic submissions guidance
    Provides general information on producing an electronic copy of a dossier in the non-eCTD electronic submission (NeeS) format, including how to prepare and structure the data.
  • Additional trade names
    New guidance for prescription medicine sponsors on preparing additional trade name applications.
  • Extension of indications
    New guidance for prescription medicine sponsors on preparing extension of indications applications that do not require supporting clinical and/or bioequivalence data.