Australian electronic Submission Basics Guide- Australia (TGA)

eCTD and NeeS are the standard electronic submission formats and allow the Common Technical Document (CTD) structure to be provided in an electronic format that is supported by specifications and validation criteria.

The TGA has published Version 1.0 of the Australian electronic submissions basics guide.

It is an introduction to the basics of electronic submissions in Australia and will be useful for users who are new to the TGA’s electronic submissions and mainly focuses on the electronic Common Technical Document (eCTD) and non eCTD electronic Submission (NeeS) formats.

This guide will cover the below topics

• eSubmissions terminology and key concepts

  • Electronic Common Technical Document (eCTD)

  • Non-eCTD electronic submission (Nees)

• Specifications

  • eCTD specifications

  • NeeS specifications

  • XML envelope

• Validation criteria

  • eCTD validation criteria

  • NeeS validation criteria

This guide was released on 21-June-2021.