Australian eCTD submissions

Related information

13 January 2016

The Australian electronic Common Technical Document (eCTD) is a specification for the pharmaceutical industry to submit electronic applications to enter registered medicines into the Australian Register of Therapeutic Goods (ARTG).

An interface between applicants (or manufacturers) and the TGA, the Australian eCTD format facilitates the validation, reviewing and electronic processing of applications.

eCTD submissions - Version 3.0

From 1 January 2016 all eCTD applications must be submitted to the TGA in AU eCTD specification version 3.0.

Useful links

ICH

eCTD news and updates

Questions and answers

We are currently preparing questions and answers to reflect the implementation of Australian eCTD specification: Module 1 and regional information, Version 3.0. In the meantime, the question and answer sessions from the pilot phase provide general and technical understanding of eCTD:

eCTD presentations