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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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AU regional content

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

Regional content refers to the Australian specific information to be included within your eCTD application.

  • Regulatory requirements and content for module 1 is described within CTD Module 1.
  • The validation criteria to support the content is described within the eCTD Validation Criteria spreadsheet in the AU Validation Criteria 3.1 Excel workbook.
  • Use the eCTD Sequence Matrix to determine what combination of sequence type and sequence description is relevant to your specific sequence.

Module 1 administrative and prescribing information

The ICH Common Technical Document (CTD) specifies that:

  • Module 1 should contain region specific administrative and product information.
  • Module 3.2.R should be used for any additional drug substance and/or drug product information specific to Australia.

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