Please note: V3.0 of the specification is acceptable until 30 June 2018. This version (V3.1) becomes effective on 1 January 2018.
We have used the World Wide Web Consortium (W3C) Schema approach to define the updated Module 1.
The following documents were referenced during the creation of this specification:
*Large file warning: Attempting to open large files over the Internet within the browser window may cause problems. It is strongly recommended you download this document to your own computer and open it from there.
- EU Module 1 eCTD Specification (pdf,503kb)*
- Guidance Document: Creation of the Canadian Module 1 Backbone (pdf,712kb)*
- The eCTD Backbone Files Specification for US Module 1 (pdf,294kb)
Factors that could affect the content of the specification include, but are not limited to:
- change in the content of the Module 1 for the CTD
- update of standards that are already in use within the eCTD
- new standards for the creating and/or using eCTD
- new functional requirements
- experience with using eCTD, in particular Module 1.
We will:
- provide a practical timeframe for future changes to minimize impact on industry.
- introduce changes at scheduled intervals to allow stability.
Please send any feedback, comments or questions to esubmissions@health.gov.au.