Change to eCTD Guidance for Industry

18.05.2018

The eCTD Guidance for Industry has been updated to version 1.9 and comprises the following points:

  • Changes to the "Formal requirements" guidance document required minor adjustments

    • Adjustments to Types of submissions

    • Adjustments to Specific requirements for documents

  • Various corrections

Please note: There was a problem with the versioning of the document. Version 1.9 is now valid and entered into force on 30 April 2018.

https://www.swissmedic.ch/content/swissmedic/en/home/services/submissions/news-submissions/anpassung-der-ectd-guidance-for-industry.html