From 1 November 2021, the Therapeutic Goods Administration (TGA) will begin a staged transition to Electronic Common Technical Document-only (eCTD-only) for all prescription medicines.
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.
Australian eCTD specifications
Australian eCTD submissions
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.
- AU eCTD specification: Module 1 and regional information v3.0 - acceptable until 30 June 2018
- eCTD AU module 1 and regional information V3.1 - effective from 1 January 2018
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)
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
Guidance
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.
- eCTD Document Matrix file download updated to version 2.1
22 June 2018 - Reminder that the transition period for current Australian regional specification ends 30 June 2018
6 June 2018
eCTD Version 3.0
- Australian regional backbone schema for module 1 (xsd,12kb)
- 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)
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:
- xml.xsd: 382b0a4f7529d2c5f7b0af0aa713b0a5
- xlink.xsd: 52d1a3b8596e4fb61d3ec1cde24be16a
- au-regional.xsd [0.9]: e6549cb8f267623f864430249068564c
- au-regional.xsd [3.0]: 25300b93cf16674c3e4c0153345322fa
The MD5 checksum values for the ICH files can be found on ESTRI website.
eCTD Version 3.1
- 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.
NeeS
- 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
- Australian eCTD regional specification and validation criteria 3.0.1 (Microsoft Excel,5.74Mb)*
- Australian eCTD regional specification and validation criteria 3.1 (Microsoft Excel,5.71Mb)*
*Large file warning: Attempting to open large files over the Internet within the browser window may cause problems. It is strongly recommended you download this document to your own computer and open from there.
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.