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.