Introduction
In May 2023, the TGA mandated the use of ICH eCTD Specification v3.2.2 for the electronic submission of regulatory information relating to all Prescription Medicines. We now look towards the adoption of ICH eCTD Specification v4.0, in line with the TGA’s continued commitment to global harmonisation.
An updated technical specification and guidance for use (Module-1 v4.0) will be published online in Q3 2024 (Stage 3 of the implementation timeline below.)
For more information on Module-1, please see TGA Guidance.
For more information on ICH eCTD v4.0, please see ICH eCTD v4.0.
Implementation timeline
Stage | Description | Status | Timeframe |
|---|---|---|---|
1 | Invited consultation with Industry Partners to assist compilation of AU Module-1 for eCTD v4.0 | Completed | Oct-Nov 2023 |
2 | Internal review of Working Group outcomes and drafting of outcomes into final draft of Module-1 v4.0 | Completed | Q1 2024 |
3 | Module-1 v4.0 published online | In development | Q3 2024 |
4 | Invitations to participate in Technical Pilot program (issued through TGA website) | In development | Q1-Q2 2025 |
5 | Commencement of a technical pilot program | In development | Q3 2025 |
6 | Voluntary adoption of Module-1 v4.0 | In development | 2026 |
7 | Mandatory adoption of Module-1 v4.0 | In development | TBD |
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.
| Date | Update Notification |
|---|---|
| June 2024 | Release of our Module-1 specification for eCTD v4.0 has been delayed by 6 months. Timelines have been adjusted at the time of this notification and we are working hard to release our specification by end Q3 2024. Our next update will be provided end August 2024. |