Document history

In order to guarantee traceability and transparency, you will find the current and previous versions of the individual eCTD regulatory documents here, plus other documents and information necessary for the eCTD submission.

Changes and updates

Updating the documents Swiss Module 1 Specification for eCTD and Swiss eCTD Validation Criteria is only foreseen in the case of major modifications. The Guidance for Industry on Providing Regulatory Information in eCTD Format and the Guidance Paragraph 13 TPA are updated annually, and the Questions & Answers are updated every six months.

 

Swiss Module 1 Specification for eCTD

  CH M1 v.1.3
status Applicable as of September, 11, 2015
specification view
dtd download
stylesheet download
examples download
Implementation guidance view
checksums view
Changes to previous version view

Swiss eCTD Validation Criteria

  Validation Criteria v1.3
status Applicable for DTD v1.3
document view
release notes for new version view

Guidance for Industry

  Guidance v1.7
status Applicable as of September, 11, 2015
document view
changes to previous version view

Guidance Paragraph 13 TPA

  Guidance Paragraph 13 TPA v1.3
status
Applicable as of September, 11, 2015
document view
changes to previous version view


Questions & Answers of Swiss eCTD Implementation

  Q&A v2.0
status
Applicable as of September, 11, 2015
document view
changes to previous version
 view