The specification for the Australian electronic Common Technical Document (eCTD) format submissions.

In late 2014, the TGA commenced a pilot of electronic Common Technical Document (eCTD) format submissions using Version 0.9 of the Australian eCTD Module 1 and Regional Specification. As a result of experience gained during the pilot and feedback provided during the consultation, the TGA has developed the final version of the Australian eCTD specification:

Readiness assessment
The pilot phase has demonstrated the feasibility of the eCTD format in Australia and now the final version of the specifications is available for incorporation of the Australian eCTD and Nees profiles into your regulatory submission publishing software package. We are targeting 1 July 2015 as the date for first receipt of Australian eCTD format submissions based on Version 3.0.