Please note: V3.0 of the specification is acceptable until 30 June 2018. This version (V3.1) becomes effective on 1 January 2018.
Version history
Version
Description of change
Author
Effective date
V0.90
Original draft publication for pilot implementation and industry review
Group Support Unit Market Authorisation Group
01/07/2014
V3.0
AU eCTD specification for official use.
Version 3.0 aligns the numbering for CTD specifications (previously 2.2) and NeeS specifications (previously 1.0) to bring all formats under one version number
Regulatory Operations Unit Market Authorisation Division
01/04/2015
V3.1
Updates to provide greater clarity and align with version 3.1 of the AU eCTD specifications and validation criteria.
Updates to Envelope
Updates to Headers and associated XML elements
Additions to Sequence Types and Sequence Descriptions to cater for MMDR recommendations.
Split of the Regulatory Activity Lead value 'Prescription' into 'Prescription-chemical' and 'Prescription-biological'
Contingent changes to cater for possibility of Work Grouping and Work Sharing
Updates to Bookmark/TOC/Hyperlink guidance
Consideration for Automation processes and planned portal
