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eCTD AU module 1 and regional information
Specification and guidance for use, V3.1
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:
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- 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.
- 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 firstname.lastname@example.org.