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Australian eCTD submissions
The Australian 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).
An interface between applicants (or manufacturers) and the TGA, the Australian eCTD format facilitates the validation, reviewing and electronic processing of applications.
eCTD submissions - Version 3.0
From 1 January 2016 all eCTD applications must be submitted to the TGA in AU eCTD specification version 3.0.
- ICH electronic Common Technical Document (eCTD)
- ICH Specification v3.2.2 (Module 2-5)
- ICH eCTD Specification and Related Files (Look for the Change Control Process (Microsoft Word document) in the Change Control paragraph)
Questions and answers
We are currently preparing questions and answers to reflect the implementation of Australian eCTD specification: Module 1 and regional information, Version 3.0. In the meantime, the question and answer sessions from the pilot phase provide general and technical understanding of eCTD:
- eCTD workshops: Question and answer sessions (13 January 2015)
- Australian eCTD submissions: Frequently asked questions (21 October 2014)
- Presentation: eCTD in Australia and experience in the pilot programme, 5-7 May 2015 (2015 ARCS Scientific Congress)
- Presentation: eSubmissions in Australia, 17 December 2014 (ARCS eCTD workshop)
- Presentation: Electronic submission requirements for prescription medicines - AU eCTD update, 15 September 2014 (2014 ARCS Scientific Congress)