AU eCTD specification: Module 1 and regional information
14 April 2015
Please note: This version (V3.0) of the specification is acceptable until 30 June 2018. Version V3.1 becomes effective on 1 January 2018.
- applies to all regulatory activities provided to us in eCTD format
- needs to be used with the ICH eCTD Specification to prepare a valid eCTD submission.
In this guidance
- Business protocol for preparing for your eCTD transaction
- AU regional content - Module 1 and the regional information of Modules 2.3.R and 3.2.R
- AU Module 1 general architecture - creating a regional backbone file to Module 1 schema
- eCTD preparation tools
- Change control
- Version history
- A subgroup of an Application which can be a group of related sequences for one approval or notification process. Usually defined for the lifecycle of the specific approval process.
- electronic Common Technical Document
- generic term that refers to an application, a regulatory activity type and/or a sequence. Often used when not referring specifically to a particular hierarchical level of the application