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AU eCTD specification: Module 1 and regional information

Version 3.0

14 April 2015

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Change control

Please note: This version (V3.0) of the specification is acceptable until 30 June 2018. Version V3.1 becomes effective on 1 January 2018.

We have used the World Wide Web Consortium (W3C) Schema approach to define the new 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@tga.gov.au.

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