Prescription medicine sponsors can now submit dossiers to the TGA 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.

For more details, go to: https://www.tga.gov.au/media-release/prescription-medicines-submissions-ectd-format-now-australia