AU regional content

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.