Australia TGA: eCTD Specification and guidance for use - AU module 1 and regional information v3.2

Sharan Murugan
18 hours ago
3 min read

The Therapeutic Goods Administration (TGA) has updated its eCTD AU Module 1 and Regional Information v3.2 guidance. A 4 September 2026 update introduced minor editorial changes and added links to the TGA page Dossier requirements for non-prescription medicines and the new user guide Submitting data in electronic Common Technical Document (eCTD) format for a non-prescription medicine application. Dossier requirements for non-prescription medicines: Submitting data in eCTD format for a non-prescription medicine application

The Version 3.2 specification became effective on 1 April 2025, with Version 3.1 accepted during a transition period until 31 October 2025. Versions 3.0 and earlier are no longer accepted.

What Has Changed from Version 3.1 to Version 3.2?

The main purpose of Version 3.2 is to better align the Australian eCTD framework with current business processes, provide greater flexibility for future requirements, improve validation consistency, and make document locations within eCTD applications more efficient.

Regulatory Activity Leads and Sequence Types

Version 3.2 introduces a new regulatory activity lead for Prescription medicines-vaccine to support vaccine data collection and removes the separate Pharmacovigilance regulatory activity lead. Pharmacovigilance sequences are now handled through appropriate sequence types and descriptions.

Several new sequence types have also been introduced. These include Minor Variation (Cat 3), Minor Editorial Change (MEC), Generic extension of indications, Pre-Advice, Designation/Determination, S14/14A, Post-requirement or Administrative, and new categories for registered complementary medicines and transition to full registration.

Existing sequence types have also been simplified or renamed. For example, separate major variation categories covering new strengths, dosage forms, routes of administration, patient groups, and dosage changes are consolidated under Major Variation. Similar simplification has been applied to minor variations and several OTC sequence types.

New and Revised Sequence Descriptions

Version 3.2 adds sequence descriptions for activities such as Partial withdrawal, Annual Report, Certified product details, Administrative update, Early scientific advice, International work-sharing information, Final, and Errors of fact or omissions.

Some existing descriptions have been simplified by removing mandatory dates or version information. For example, the Risk Management Plan description is now RMP, while response and evaluation-related descriptions no longer require dates in the description.

Some descriptions have also been removed where the activity can now be represented through another sequence description, such as meeting minutes and risk communication documents being captured under Administrative update.

Module 1 Heading and Document Structure Changes

Version 3.2 introduces clearer distinctions between different versions of important documents.

For package inserts, the previous Package insert heading has been changed to Package insert—clean, with additional headings for annotated and approved package inserts.

Similarly, the Risk Management Plan structure now distinguishes between clean, annotated, and approved versions. New headings have also been added for the Australian Specific Annex—clean, annotated, and approved, as well as other RMP materials.

Another important structural update is the addition of M6.1 Medical Device to the AU Module 1 folder structure. This provides a location for information relating to medical devices, companion diagnostics, drug delivery apparatus, or other diagnostic aids associated with combination applications.

Changes to Validation Requirements

Version 3.2 also updates the Australian eCTD validation criteria to provide clearer and more consistent validation requirements.

A significant change is the introduction of requirements for a warnings.xml file. When a sequence contains priority validation warnings, the file must be present in the sequence root folder, and the relevant warnings should be justified within it.

The validation rules for file extensions, sequence folder naming, leaf operations, and other technical elements have also been updated. The severity of the foreign regulatory status operation finding has been reduced from an Error to a Warning. The guidance also states that use of content blocks is not recommended.

The TGA has also expanded allowable file types to include .txt and .doc, reflecting increased collaboration and situations where unstructured data may not be suitable for PDF or XML formats.

Changes to Work-Sharing and Partial Withdrawals

The TGA does not accept work-sharing sequences, as it considers the practice to have limited utility within its eCTD application assignment process.

Work-grouping remains available for bundled minor variation submissions, but it is not accepted for submissions outside the minor variation pathway.

Version 3.2 introduces Partial Withdrawal to support withdrawal of part of a bundled minor variation sequence. This allows a sponsor to remove a specific submission from evaluation without withdrawing the entire sequence.

The partial withdrawal process requires the sequence to be appropriately linked to the original bundled submission and the relevant documents to be removed using the applicable eCTD lifecycle operations.

For sponsors, the key change is not simply moving to a new version, but ensuring that submission classification, sequence metadata, document placement, lifecycle management, and validation practices are aligned with Version 3.2 requirements.