Australia Guidance

The Australian Therapeutic Goods Administration (TGA) has finalized regional specification and validation criteria for eCTD format submissions. The final eCTD specification was the result of a pilot program and feedback from interested parties.

On July 3, 2015, Australia’s TGA announced that prescription medicine sponsors were permitted to begin submitting eCTD format submissions based on version 3.0.

Following the success of the country’s pilot programme between January 2015 and June 2015, eCTD format submissions no longer require an accompanying paper dossier.

Paper dossiers are also not required when filing Non-eCTD electronic submissions (NeeS).

The TGA is currently updating guidance documents to reflect that paper copies are no longer required.

Submissions using version 3.0 of the eCTD specification will be valid starting June 1, 2015. Submissions using version 0.9 of the eCTD specifications are valid until December 31, 2015.

TGA will continue to accept NeeS format submissions and has included a revised NeeS format to match the new eCTD format in the validation criteria.

Primary Guidance Documents

AU eCTD specification – Module 1 and regional information, Version 3.0

AU eCTD regional specification and validation criteria 3.0 (Microsoft Excel)

Related Materials

eCTD Workshops: Question and Answer sessions, January 13, 2015

Business protocol for preparing for your eCTD transaction

AU regional content – Module 1 and the regional information of Modules 2.3.R and 3.2.R

AU Module 1 general architecture – creating a regional backbone file to Module 1 schema

eCTD preparation tools

Change control

Version history

Australian eCTD File Downloads

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)