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.1.4
status  Applicable as of 01 November 2018
specification  view (PDF, 2 MB, 01.11.2018)
dtd  download (ZIP, 3 kB, 01.11.2018)
stylesheet  download (ZIP, 5 kB, 01.11.2018)
examples  download (ZIP, 886 kB, 01.11.2018) 
Implementation guidance  view (PDF, 463 kB, 01.11.2018)
checksums  view (TXT, 195 B, 01.11.2018)
Changes to previous version  view (PDF, 1 MB, 01.11.2018)
Swiss eCTD Validation Criteria
   Validation Criteria v1.4
status  Applicable for DTD v1.4
document  view (XLS, 486 kB, 01.11.2018)
release notes for new version  view (XLS, 476 kB, 01.11.2018)
Guidance for Industry
   Guidance v1.10
status  Applicable as of 01 October 2018
document  view (PDF, 1 MB, 01.10.2018)
changes to previous version  view (PDF, 1 MB, 01.10.2018)
Guidance Article 13 TPA
   Guidance Article 13 TPA v1.4
status  Applicable as of 01 October 2018
document  view (PDF, 809 kB, 01.10.2018)
changes to previous version  view (PDF, 601 kB, 01.10.2018)
Questions & Answers of Swiss eCTD Implementation
   Q&A v2.0
status Applicable as of 01 October 2015
document  view (PDF, 379 kB, 31.05.2018)
changes to previous version  view (PDF, 544 kB, 01.10.2015)
https://www.swissmedic.ch/content/swissmedic/en/home/services/submissions/ectd/dokumentenhistorie.html