Module-1 v3.1 of the specification is being reformed. Milestones and updates can be found on the Module-1 v3.2 implementation plan.
We are adopting ICH eCTD v4.0 specification. Milestones and updates on the regional specification can be found on the Module-1 v4.0 implementation plan.
Introduction
This document applies to all regulatory activities in electronic Common Technical Document (eCTD) format.
The document contains:
- user guide for compiling an eCTD dossier
- specifications for compiling and validating your eCTD regulatory activity.
This document replaces AU eCTD specification - Module 1 and regional information Version 3.0 and contains updated information. A summary of the updates are provided with the Summary section.
Version 3.1 of the specifications and validation criteria will come into effect in 2018 following a transition period and should be read in combination with Australian validation criteria version 3.1, eCTD schemas and related files.
| File type | File description | File name | File checksum value |
|---|---|---|---|
| Schema | Australian regional backbone | au-regional.xsd | 4fd79acbc42fe34ee27d05e144b1d844 |
| Stylesheet | Australian regional backbone | au-regional.xsl | N/A |
| Stylesheet | Codes / defined list | codes.xsl | N/A |
| Stylesheet | Sequence matrix | sequence-matrix.xsl | N/A |
| Stylesheet | Document matrix | document.matrix.xsl | N/A |
| Codes / defined list | Regulatory activity lead | reg-activity-lead.xml | 98a0e9939c9bdd5fc223ba8824fcf1ae |
| Codes / defined list | Sequence type | sequence-type.xml | acfbb6118afdcf312603973bcf74aae7 |
| Codes / defined list | Sequence description | sequence-description.xml | 59f1d9d67e96adff8e0713fd929e5f7d |
| Codes / defined list | Sequence matrix | sequence-matrix.xml | 115b4ad695d5822430ce5014ddb25f04 |
| Codes / defined list | Document matrix | document-matrix.xml | 2dc2ef984dadf26a4188f601fa25c13b |
| Spreadsheet | eCTD Validation Criteria v3.1 | Australian eCTD validation criteria v3.1 | N/A |
Summary of updates in Version 3.1
The following eCTD documents and specifications have been updated as part of the upgrade to version 3.1:
- AU eCTD specification Module 1 and regional information (this document)
- Australian eCTD regional specification and validation criteria, eCTD XML schema and related files
- Checksum values
- AU 3.1 eCTD sample submissions
For a comprehensive understanding of the updates introduced in version 3.1 please refer to the to the AU Validation Criteria v3.1 where all updates (both new and changes) been highlighted in yellow. Updates within the validation criteria have been reflected within the XML schemas, related files and checksum values.
For further information on any of the updates please contact esubmissions@health.gov.au.
Purpose of the updates
- Support the implementation of the Medicine and Medical Device Review (MMDR) recommendations; including the priority, provisions and notification pathways.
- Allow for the possibility of eCTD dossiers supporting requests for multiple changes (see further references in this document to 'Work sharing' and/or 'work grouping').
- Provide greater clarity to users.
- Enhance dossier quality (introduce additional validation criteria to assist with dossier quality).
- Allow for automation of some process steps within the TGA.
Summary of eCTD updates
Module 1 Section updates
| New sections | Rationale |
|---|---|
| 1.3.1.3 Product Information - approved | The inclusion of an approved folder clearly distinguishes the approved copy from the working copies |
| 1.3.2.3 Consumer Medicine Information - approved |
| Updated sections | Previous | Rationale |
|---|---|---|
| 1.3.1.4 Package insert | 1.3.1.3 Package insert | Moved section ID to accommodate Product Information – approved |
1.3.3.1 Label mock-ups and specimens – clean 1.3.3.2 Label mock-ups and specimens – annotated 1.3.3.3 Label mock-ups and specimens – approved | 1.3.3 Label mock-ups and specimens | Section has been divided to clearly distinguish the clean, annotated and newly added approved copies. |
Sequence Type updates
| New | Rationale |
|---|---|
| Provisional registration – TGA initiated variation | Support MMDR recommendation implementation |
| Notification | |
| CN | |
| Extension of provisional registration | |
| Duplicate | Requirement inclusion for potential work sharing options. |
A new sequence description 'Provisional approval – rolling data submission' has also been included to support the implementation of MMDR.
Where known, additional document requirements have been included within the Document Matrix for each of these new sequence types. As more detail on document requirements becomes available, we will update the Document Matrix that appears on the TGA website.
| Updated Sequence Type | Previous | Rationale |
|---|---|---|
| Product Withdrawal | Withdrawal | Name change to better align with the use of this sequence type. Validation criteria have also been amended. |
XML elements
Addition of new XML elements within the AU envelope has been included to build additional capacity into the envelope and allow for future automation of the validation process.
eCTD validation criteria
Updates to the validation criteria for eCTD have been included within version 3.1.
New validation criteria have been included to primarily support the introduction of new XML elements. Updates have also been made to some current criteria to provide further clarity based on experience gained to date.
Please refer the eCTD Validation Criteria within the AU Validation Criteria version 3.1 for further details on updated items.
Terminology
It is acknowledged that the terminology to describe regulatory activities and electronic submissions differs between regions. To assist users interpret this user guide and specification a brief list of terms used is described below:
| Term | Definition |
|---|---|
| eCTD | electronic Common Technical Document - an electronic standard for the Common Technical Document (CTD) providing the means for transferring information from pharmaceutical companies to agencies. |
| *eCTD application | for the purpose of this document - refers to a collection of electronic documents filed under an e-Identifier and comprises of a number of sequences and regulatory activities. |
| Envelope | Contains the metadata relevant to the eCTD sequence. Metadata are referred to as envelope elements. |
| e-Identifier | is a combination of a letter and six digits, for example e123456. It is the unique identifier for the eCTD application that tracks the products for the entire lifecycle (previously eSubmission Identifier). |
| leaf | Structural element of an eCTD submission delivering a document. It provides the link information to the document along with the title associated with the linked content. |
| NeeS | Non-eCTD Electronic Submission - an alternative electronic standard to eCTD consisting of PDF Files and PDF Table of Contents linking all content for navigational purposes. |
| regulatory activity | a collection of sequences covering a specific request. Referred to in Australia as a submission e.g. Submission for a new chemical entity (NCE). |
| sequence | a sequence is a package of information bundled together in an electronic structure providing information to the agency. The contents of a sequence will depend on the regulatory activity type and whether it is the initial sequence of the regulatory activity or a follow-up providing additional data or changes. |
| Stream | An indication of the clinical team that will deal with a request to register a new product. Each stream corresponds to a therapeutic category. These are available on the TGA website. |
*Within Australia the words 'submission' and 'application' have very specific meanings within our regulatory framework and legislation. To avoid confusion eCTD application will be used to describe eCTD related terminology rather than application.
Implementation/transition plan
To allow for planning and software updates we have incorporated a transition period for the uptake of the AU eCTD version 3.1 specifications.
Version 3.0 was the first official eCTD version for Australia.
The initial version of this specification was identified as 0.90 to indicate its draft status and versions 1.0 and 2.0 were skipped to avoid confusion with past CTD guidance.
Timelines for implementation of version 3.1
- The AU eCTD version 3.1 specification will be effective starting 1 January 2018.
- The AU eCTD version 3.0 specification will be accepted until 30 June 2018.
- The AU eCTD version 0.90 specification was used for the eCTD pilot and is no longer accepted.
Between 1 January 2018 and 30 June 2018 we will accept both the new version 3.1 and the 'old' version 3.0 of the specification.