TGA Australia – Paper Dossiers are no Longer Required to Accompany eCTD

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.

“See TGA Announcment”:http://www.tga.gov.au/media-release/prescription-medicines-submissions-ectd-format-now-australia for complete information.

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