Electronic submissions

18 October 2017

Today the TGA formally released the update AU Module 1 specifications for both eCTD and NeeS. The updated specifications will be available for use from 1 January 2018 and will cater for MMDR innovations, specifically Priority Review and Provisional Approval pathways. The existing specifications will be acceptable for use until 30 June 2018.

An electronic Submission (or eSubmission) is a set of registration files submitted in electronic form for the registration, or a variation to the registration, of a medicine. It is a set of files (Portable Document Format (.pdf), Microsoft Word files (.doc) or Rich Text Format (.rtf) and picture files like jpeg etc.) submitted in folders according to the current CTD format.

An electronic Common Technical Document (eCTD) is the electronic submission of registration files that are organised according to the ICH eCTD specifications (version 3.2.2) and the current version of the AU Module 1 specifications.

Other structures or formats may also be accepted, such as a Non eCTD electronic Submission (NeeS).

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.

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

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.


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.

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.

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: 33d00b4f668d5a587dd4c28ca4cdaea9
  • 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 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

How to access an Excel document

*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.


Contact details

esubmissions@tga.gov.au