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eCTD AU module 1 and regional information

Specification and guidance for use, V3.1

18 October 2017

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AU regional file formats

Please note: V3.0 of the specification is acceptable until 30 June 2018. This version (V3.1) becomes effective on 1 January 2018.

File formats refers to the accepted file type for documents within a sequence.

Module 1

In addition to PDF, as defined by the ICH eCTD Specification Document, we will also accept XML.

Currently, there are no structured exchange standards for content, but these may be introduced in the future for content such as the lifecycle management tracking table, application forms, product information, etc.

Where possible, generate PDFs from an electronic source. Signatures may be embedded as a graphic file in the PDF.

All PDF files, in any module, should be v1.4, v1.5, v1.6 or v1.7 except where a specific requirement for a later version is defined.

Module 2 to 5

In addition to the file formats defined for Modules 2 to 5 in the ICH eCTD Specification and the ICH specifications for study tagging files, we will allow comma separated value (CSV) and plain text (TXT) files in Modules 4 and 5 to allow for specialist analysis—for example, population pharmacokinetics analysis.

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