The TGA has published Version 1.0 of the Australian electronic submissions basics guide.
The guide is entitled Australian electronic submission basics eCTD and NeeS Basics
Who is the guide for?
It is for users who are new to the TGA’s electronic submissions. It is an introduction to the basics of electronic submissions in Australia.
What does the guide focus on?
It focuses on the electronic Common Technical Document (eCTD) and non eCTD electronic Submission (NeeS) formats.
What are the main topics covered in the guide?
The main topics covered are:
- 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
Source: TGA Website