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AU eCTD specification: Module 1 and regional information

Version 3.0

14 April 2015

Book pagination

Version history

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

When new versions are released, there will be an implementation of at least six months in which we will accept both the new and old versions of the specifications to allow planning and software updates.

The AU eCTD version 3.0 specification will be effective starting 1 June 2015.

The AU eCTD version 0.90 specification will be accepted until 31 December 2015.

Version 3.0 is the first official eCTD version for Australia.

  • The initial version of this specification was identified as 0.90 to indicate its draft status.
  • Versions 1.0 and 2.0 have been skipped to avoid confusion with past CTD guidance.
Table: 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

Book pagination