Introduction
We are working in collaboration with industry partners to reform our existing eCTD AU Module 1 and Regional Information – specification and guidance for use v3.1 (Module-1 v3.1) to ensure our regional requirements are fit-for-purpose and align with current business needs.
The purpose of the update from Module-1 v3.1 to v3.2 is to enhance dossier quality and provide greater clarity to users by:
- Amending the defined lists and matrices to ensure they align with current business processes and incorporate flexibility to adapt to future needs.
- Reviewing the Australian eCTD validation criteria to ensure they provide clear and consistent requirements.
- Amending eCTD AU Module 1 heading elements to ensure they are descriptive, accurate, and comprehensive.
An updated technical specification and guidance for use (Module-1 v3.2) has been published.
Full specification: eCTD AU Module 1 and Regional Information v3.2
Summary of changes: eCTD AU Module 1 v3.2 Summary of changes
Module-1 v3.2 is to be used in conjunction with ICH eCTD Specification v3.2.2 for the electronic submission of regulatory information relating to all Prescriptions Medicines.
Implementation timeline
Stage | Description | Status | Timeframe |
|---|---|---|---|
1 | Invited consultation with Industry Partners to review and reform Module-1 v3.1 | Completed | Oct-Nov 2023 |
2 | Internal review of Working Group outcomes and drafting of outcomes into final draft of Module-1 v3.2 | Completed | Apr 2024 |
3 | Module-1 v3.2 published online | Completed | Sep 2024 |
4 | Voluntary adoption of Module-1 v3.2 | In development | Apr 2025 (TBC) |
5 | Mandatory adoption of Module-1 v3.2 (Module-1 v3.1 no longer accepted) | In development | Oct 2025 |
Progress updates
Please check this page for updates on our progress and for any other changes. Major updates to the project timeline will be communicated through the Electronic submissions and the Module-1 v3.1 specification and guidance pages, in addition to the TGA eSubmissions SharePoint portal.
Please contact us at EDR@health.gov.au if you have any questions relating to the update of eCTD AU Module 1 and Regional Information at TGA.