Introduction
Electronic Submissions (or eSubmissions) are the electronic presentation of information submitted to the TGA, or other regulators, in a standardised paper-less structure.
Electronic Common Technical Document (eCTD) and Non eCTD electronic Submission (NeeS) are the standard electronic formats. Other structures or formats may also be accepted.
eCTD AU Module 1 v3.2 specification and regional information has been published.
The full specification and summary of changes can be found on the website. Additional 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.
Australian eCTD specifications
The electronic Common Technical Document (eCTD) is a specification for the pharmaceutical industry to submit electronic applications to enter registered medicines into the Australian Register of Therapeutic Goods (ARTG) and is organised according to current Australian and ICH eCTD specifications.
- eCTD AU module 1 and regional information v3.1 - effective from 1 January 2018 to August 2025
- eCTD AU module 1 and regional information v3.2 - effective from February 2025
The current ICH eCTD specification is ICH eCTD Specification V3.2.2.
The eCTD is the submission of (mostly) PDF leaf documents, stored in the eCTD directory structure, accessed through the XML backbone (index.xml) and with the files integrity guaranteed by the MD5 Checksum.
Useful links
- Submitting data in the eCTD format
- Electronic submissions and data review
- Australian eCTD submissions: Frequently asked questions
- ICH electronic Common Technical Document (eCTD)
- ICH Specification v3.2.2 (Module 2-5)
- ICH eCTD Specification and Related Files (Look for the Change Control Process (Microsoft Word document) in the Change Control paragraph)
Non eCTD electronic Submission (NeeS)
The NeeS format should be considered as a transition stage towards the eCTD format.
A NeeS differs from an eCTD in that it does not contain an XML backbone or the quantity of MD5 checksum values as defined by the ICH - it is in essence, a collection of electronic files organised in folders.
However the NeeS module 1 version 2.0 does introduce an Excel form that is to be used to create an XML envelope. Also a NeeS version of the XML Sequence matrix with associated MD5 checksum value.
- AU NeeS specification: Module 1 and regional information - acceptable until 30 June 2018
- AU NeeS specification: Module 1 and regional information, V2.0 - effective from 1 January 2018
- Submitting data in the NeeS format
Guidance
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Reference materialNew Australian Electronic Submission Basics guidance available
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User guideUser guide on how to submit data in the electronic Common Technical Document (eCTD) format.
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User guideUser guide for sponsors and manufacturers wanting to submit data in the NeeS format.
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User guideUser guide for sponsors converting their dossier format from paper, CTD or NeeS to eCTD
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User guideUser guide for sponsors who need to withdraw information from their eCTD dossiers and can be used as best practice for NeeS withdrawals
File downloads
The eCTD XML schema and related files are available below and allow the possibility of automated access by eCTD publishing tools. Please ensure you are using the correct versions.
- 22 June 2018 - eCTD Document Matrix file download updated to version 2.1
- 6 June 2018 - Reminder that the transition period for current Australian regional specification ends 30 June 2018
- Australian regional backbone schema for module 1 (xsd,14kb)
- Style sheet for Australian regional backbone (xsl,28kb)
- W3C schema for XLink1.1 (xsd,10kb)
- W3C schema for XML namespace (xsd,6kb)
- Style sheet for the code files (xsl,3kb)
- Codes and defined lists for Regulatory Activity Lead (xml,1kb)
- Codes and defined lists for Sequence Description (xml,4kb)
- Codes and defined lists for the Sequence Type (xml,6kb)
- eCTD Document Matrix (version 2.1) (xml,98kb)
- Style sheet for eCTD Document Matrix (version 2.0) (xsl,19kb)
- eCTD Sequence Matrix (version 2.0) (xml,2kb)
- Style sheet for eCTD Sequence Matrix (version 2.0) (xsl,6kb)
The TGA has made available a sample eCTD submission with three sequences:
Checksum values
The MD5 checksum values of the files published by the TGA are listed below:
- au-regional.xsd: 4fd79acbc42fe34ee27d05e144b1d844
- xlink.xsd: 52d1a3b8596e4fb61d3ec1cde24be16a
- xml.xsd: 382b0a4f7529d2c5f7b0af0aa713b0a5
- document-matrix.xml: 2dc2ef984dadf26a4188f601fa25c13b
- reg-activity-lead.xml: 98a0e9939c9bdd5fc223ba8824fcf1ae
- sequence-description.xml: 59f1d9d67e96adff8e0713fd929e5f7d
- sequence-type.xml: acfbb6118afdcf312603973bcf74aae7
- sequence-matrix.xml: 115b4ad695d5822430ce5014ddb25f04
The MD5 checksum values for the ICH files can be found on ESTRI website.
- Australian regional backbone schema for module 1
- Style sheet for Australian regional backbone
- W3C schema for XLink1.1
- W3C schema for XML namespace
- Style sheet for the code files
- Codes and defined lists for Regulatory Activity Lead
- Codes and defined lists for Sequence Description
- Codes and defined lists for the Sequence Type
- eCTD Document Matrix (version 3.0)
- Style sheet for eCTD Document Matrix (version 3.0)
- eCTD Sequence Matrix (version 3.0)
- Style sheet for eCTD Sequence Matrix (version 3.0)
Checksum values
The MD5 checksum values of the files published by the TGA are listed below:
- au-regional.xsd: efec6508c4ee0bfcf66326946852a535
- xlink.xsd: 52d1a3b8596e4fb61d3ec1cde24be16a
- xml.xsd: 382b0a4f7529d2c5f7b0af0aa713b0a5
- document-matrix.xml: df9426922110d3eb337463d78f80d386
- reg-activity-lead.xml: 4f4fcea183a5673dd8e722856ee4f206
- sequence-description.xml: 11c196f2c0e75682e98e52b0b9c67c48
- sequence-type.xml: 4ef5f6090034ce3d8ad417a79ad45bd4
- sequence-matrix.xml: 07c495fa86ecaf6403b060a3d54ede66
- NeeS Sequence Matrix (version 2.0) (xml,2kb)
- Style sheet for NeeS Sequence Matrix (version 2.0) (xsl,6kb)
- NeeS envelope form (xlsx,19kb)
Checksum values
The MD5 checksum values of the file published by the TGA is listed below:
- sequence-matrix-nees.xml: 7a048c972050fb7ec7969cd50bfd71e4
Validation
Submissions, in either NeeS or eCTD format, must have no validation errors and minimal warnings in order to be accepted.
Australian eCTD specification and criteria
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Australian eCTD regional specification and validation criteria 3.0.1 [Excel, 5.75 MB]
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Australian eCTD regional specification and validation criteria 3.1 [Excel, 5.72 MB]
Validation tools
The following vendors have provided links to their validation tools which may be used to ensure submissions are acceptable:
If you think additional validation tools should be listed here, please send a request to esubmissions@tga.gov.au and include relevant information for assessment.