14 July 2026

Swissmedic has published version 1.1 of the Swiss Implementation Guide package for the future implementation of the eCTD v4.0 standard for electronic medicinal product submissions. The package includes the Swiss Implementation Guide, controlled vocabulary lists and validation criteria, providing the technical specifications required for software developers and applicants to prepare compliant electronic submissions in Switzerland. Swissmedic plans to complete the technical implementation of eCTD v4.0 by the end of 2026, with the new standard expected to go live during 2027 following pilot testing. To ensure a smooth transition, the current eCTD v3.2.2 standard will remain supported for several years. Swissmedic also announced that the implementation requirements will be refined on an ongoing basis, with a final version of the guidance expected by early 2027 and FAQs to be published after completion of the pilot phase.

For more information, see here.