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 eCTD Validation Criteria
   Validation Criteria v1.5 Legacy version: v1.4
status  Applicable for DTD v1.5 For reference only
document  view (XLS, 76 kB, 01.04.2020) view archive (XLS, 94 kB, 01.11.2018)
release notes for new version  view (XLS, 222 kB, 14.10.2020)  
Guidance for Industry
   Guidance v1.11 Legacy version: v1.10
status  Applicable as of 01 April 2020 For reference only
document  view (PDF, 1 MB, 01.04.2020) view archive (PDF, 1 MB, 01.10.2018)
changes to previous version  view (PDF, 1 MB, 01.04.2020)  
Guidance Article 13 TPA
   Guidance Article 13 TPA v1.5 Legacy version: v1.4
status  Applicable as of 01 April 2020 For reference only
document  view (PDF, 787 kB, 01.04.2020) view archive (PDF, 401 kB, 01.10.2018)
changes to previous version  view (PDF, 782 kB, 14.10.2020)  
Questions & Answers of Swiss eCTD Implementation
   Q&A v2.2 Legacy version: v2.1
status Applicable as of 01 April 2020 For reference only
document  view (PDF, 500 kB, 01.04.2020) view archive (PDF, 182 kB, 18.01.2019)
https://www.swissmedic.ch/content/swissmedic/en/home/services/submissions/ectd/dokumentenhistorie.html