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eCTD AU module 1 and regional information

Specification and guidance for use, V3.1

18 October 2017

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Change control

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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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.

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