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Australian electronic submission basics
eCTD and NeeS Basics
Last updated
This information is for users who are new to the TGA's electronic submissions. It is an introduction to the basics of electronic submissions in Australia, focusing on the electronic Common Technical Document (eCTD) and non eCTD electronic Submission (NeeS) formats.
Contents
- eSubmissions
- eSubmissions terminology and key concepts
- Electronic Common Technical Document (eCTD)
- Non-eCTD electronic Submission (NeeS)
- Organisation of information in eCTD and NeeS
- Specifications
- eCTD specifications
- NeeS specifications
- XML envelope
- Validation criteria
- eCTD validation criteria
- NeeS validation criteria
- Version history
Supporting documents
Australian Electronic Submission Basics
[PDF, 188.53 KB]
Australian Electronic Submission Basics
[Word, 155.54 KB]