Switzerland

Swissmedic is implementing the ICH eCTD v4.0 standard as an upgrade of the current v3.2.2. Technical implementation is planned to be completed by end of 2026, after which the standard will go live during 2027 once pilot testing is complete. The current v3.2.2 will continue to be supported throughout a transition phase lasting several years. The Swiss Implementation Guide v1.1 was published on 27 July 2026 (comprising IG v1.1, controlled vocabulary CV v1.1 and Validation Criteria v1.1) as the baseline for eCTD v4.0 software development; its successor, the Swiss Implementation Guide v2.0, was published on 26 October 2026 (comprising IG v2.0, controlled vocabulary CV v2.0 and Validation Criteria v2.0, including Genericicode), superseding the v1.1 package; an FAQ list is planned for spring 2027 once the pilots are complete.

Source discrepancy: the ICH regional implementation table projects a 2026 pilot and 2030 mandatory adoption for Switzerland, whereas Swissmedic's announcement of 6 November 2026 sets the pilot at January–April 2027 and, as of November 2026, no mandatory date has been announced — the transition phase will last several years. Swissmedic's page takes precedence: the pilot date on this page and in the global table follows the authority, while the voluntary and mandatory dates remain ICH projections. Existing v3.2.2 filings are unaffected and remain valid; do not hold back current v3.2.2 submissions waiting for v4.0.

eCTD v3.2.2 is the standard on which Swissmedic's current eCTD solution is based and is Switzerland's accepted format. It builds on the ICH CTD (5 modules) and ICH technical specification V3.2.2: Module 1 is Switzerland-specific (Swiss Module 1), while Modules 2–5 are internationally harmonised. Swissmedic regulates and describes eCTD submissions through the 'Swiss M1 Specification for eCTD', the 'Swiss eCTD Validation Criteria' and the 'Guidance for Industry'; applicants must validate the technical correctness of the electronic data in advance.

After v4.0 goes live, v3.2.2 will continue to be accepted by Swissmedic throughout a transition phase lasting several years. The regional Module 1 specification, validation criteria and industry guidance are collected on the eCTD overview page; the current Swiss-specific Module 1 specification is v1.5 (published 18 Jul 2024).