Australia

TGA published eCTD v4.0 AU module 1 and regional information in April 2025. It is explicitly a draft, not a final specification: the document states it will be revised and finalised after its pilot phase, so it is for directional reference only. The draft aligns with the ICH eCTD v4.0 Implementation Guide (IG v1.6; the TGA draft dates from April 2025 — the ICH has since updated to v1.7 in June 2026, not yet reflected by TGA) and covers the Australian regional Module 1; Modules 2–5 follow the ICH eCTD v4.0 specification directly, with no TGA-specific overlay. TGA opened a technical pilot in late 2025, with participation by email registration.

Do not build a switch plan on this draft yet: it does not include custom mapping of TGA-specific information within the Document Reference, Document and Keyword Definition elements, and TGA states that dates may change as the work progresses. Note also a divergence of baselines — the global rollout table on this site follows the ICH regional implementation table (Australia listed with a 2028 pilot and 2029 voluntary acceptance), while TGA has already opened its technical pilot in 2025; where the two disagree, TGA's own site prevails, as the ICH table has not been updated. Register for the pilot or ask specification questions via EDR@health.gov.au.

The eCTD baseline TGA currently mandates. Modules 2–5 follow the ICH eCTD v3.2.2 specification; Module 1 (Australian administrative information) is defined by *eCTD AU module 1 and regional information v3.2*, whose backbone uses schema-version="3.2" and is intended for use with the W3C schema for XLink 1.1 and XML namespace. AU M1 v3.2 took effect on 1 April 2025 with a six-month transition to 31 October 2025, during which v3.1 and v3.2 were both accepted; it became mandatory on 1 November 2025, and v3.1 and earlier are no longer accepted. The mandate covers all prescription medicine applications including master files (DMFs); biologicals, over-the-counter medicines, registered complementary medicines, assessed listed medicines and ingredients for listed medicines may use eCTD voluntarily.

Only AU M1 v3.2 is accepted from 1 November 2025. Changes from v3.1 centre on headers and XML elements, sequence types and descriptions, and the validation criteria and warning-reporting process, plus the introduction of Work Grouping, removal of the 'Pharmacovigilance' regulatory activity lead value and an expansion of allowable file types — confirm your publishing tool is configured for TGA specification v3.2 before switching, or sequences will be stopped at technical validation. Sequences must be self-validated with all warnings eliminated or justified; sequences containing errors are not accepted.