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AU eCTD specification: Module 1 and regional information

Version 3.0

14 April 2015

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eCTD preparation tools

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 do not mandate or recommend any particular software to prepare an eCTD submission.

We recommend you, as the applicant:

  • Prepare the eCTD using an authenticated commercial eCTD preparation software.

    There is a wide variety of options available, both in terms of multiple vendors and of approaches - for example:

    • installed software
    • software as a service
    • service providers.
  • Find a solution which supports current and ongoing AU eCTD requirements and meets your overall business needs.
  • Validate the prepared regulatory activity using an authenticated commercial eCTD validation tool.

These validation tools are not just XML checkers or parsers, but evaluate the technical content of the regulatory activity. We recommend, you use a validation tool that:

  • supports checking current and ongoing AU eCTD requirements
  • minimises the possibility of technical validation errors which can cause delays in the overall regulatory process.

Vendors of validation tools that demonstrate their tools are in-line with validation criteria will be added to the list on our website.

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