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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.
From 1 January 2016, sponsors must submit their application using version 3.0 if submitting in the eCTD format.
About eCTD
The Australian eCTD format is a specification for the pharmaceutical industry to submit electronic applications to register medicines on the Australian Register of Therapeutic Goods (ARTG).
The eCTD format enables the faster, safer and more consistent exchange of information between the TGA and industry. It allows the TGA to conduct review processes for quality, safety and efficacy electronically.
The eCTD format supports the Australian Government's digital transition policy, and will:
deliver significant cost savings to industry, by eliminating the cost of shipping and archiving paper dossiers
cut red tape and it make it easier and more reliable to conduct business
reduce the impact on the environment, and
allow sponsors to reuse electronic dossier information when they submit their application to other regulatory authorities
