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Electronic submissions

XML schema and related files to assist with compiling a NeeS or eCTD dossier.

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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.

The current ICH eCTD specification is ICH eCTD Specification V3.2.2 - external site.

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.

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.

Guidance

  • eCTD baseline sequences

    User guide
    User guide for sponsors converting their dossier format from paper, CTD or NeeS to eCTD

  • eCTD withdrawals

    User guide
    User 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

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.

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

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

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.

Contact details

esubmissions@tga.gov.au

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