Technical documents

The Swissmedic-specific documents, including their validity status, are listed here. Previous versions with highlighted changes are also available.

In the event of technical or process-related changes to the eCTD solution, the documents are modified accordingly and sufficient transitional periods ensured.

 

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 v1.8
status Applicable as of May, 03, 2017
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