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TGA Module 1 specifications for electronic Common Technical Document (eCTD) submissions

Module 1 is the section that contains administrative information about your electronic Common Technical Document (eCTD) submission specific to Australia.

Last updated

The instructions for supplying administrative information are in eCTD AU module 1 and regional information v3.2.

Follow these specifications to ensure Module 1 of your eCTD submission is compliant.

To complete the rest of your eCTD submission, you must follow version 3.2.2 of ICH specifications for eCTD Modules 2 - 5.

You should use eCTD Module 1 specifications with W3C schema for XLink 1.1 and XML namespace.

We are adopting version 4.0 of ICH specifications

We published version eCTD v4.0 AU module 1 and regional information in April 2025. This aligns with our plans to adopt version 4.0 of ICH specifications for eCTD Modules 2 - 5.

We invite you to participate in a technical pilot program in late 2025 - email us at EDR@health.gov.au to register your interest.

Get help

If you have any questions about these changes, email us at EDR@health.gov.au.

As we progress our work, dates may change. We will update this page with any new information.

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Page history

Show all page updates (1)
  • Minor content updates to reflect that eCTD AU module 1 and regional information v3.2 became mandatory on 1 November 2025.
  • Removed section 'Module 1 specifications are changing'.
  • Minor content updates to reflect that eCTD AU module 1 and regional information v3.2 became mandatory on 1 November 2025.
  • Removed section 'Module 1 specifications are changing'.