eCTD submission

Australia (AU-TGA) Now Accepts eCTD Without Paper Copies

Prescription medicine sponsors can now submit dossiers to the TGA (Therapeutic Goods Administration) in the electronic Common Technical Document (eCTD) format. Paper dossiers are no longer required to accompany eCTD formatted submissions, following the success of the pilot programme between January and June 2015. Paper dossiers are also not required to accompany Non-eCTD electronic Submissions (NeeS). Guidance documents are currently being updated to reflect that paper copies are no longer required.

Transition period

More information go to below link:
Until 31 December 2015, applicants have the option to use either the version 0.9 or 3.0 specification for their submission:
Submissions in version 3.0 are valid from 1 June 2015 onwards.
Submissions in version 0.9 will be accepted until 31 December 2015.
From 1 January 2016, sponsors must submit their application using version 3.0 if submitting in the eCTD format.
https://www.tga.gov.au/media-release/prescription-medicines-submissions-ectd-format-now-australia

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