Prescription medicines: Submissions in the eCTD format now in Australia

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.

Transition period

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.

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