Swissmedic has published Version 2.0 of the Swiss Implementation Guide package for eCTD v4.0, replacing the previously released Version 1.1.
The update was published on 26 October 2026 and introduces multiple amendments and updates to the technical documentation that will support future eCTD v4.0 submissions in Switzerland. 1793080354110
What Is eCTD v4.0?
The electronic Common Technical Document (eCTD) v4.0 is a technical standard developed by the International Council for Harmonisation (ICH) for electronic submission of marketing authorisation applications for medicinal products.
It represents an evolution of the current eCTD v3.2.2 standard, on which Swissmedic’s existing electronic submission solution is based. 1793080354110
The new version is intended to support more modern and internationally harmonised regulatory submission processes.
Swissmedic Implementation Timeline
Swissmedic plans to complete the technical implementation of eCTD v4.0 by the end of 2026.
The standard is then expected to go live during 2027, following completion of pilot testing. 1793080354110
The objective is to ensure international compatibility with other regulatory authorities in relation to marketing authorisation submission requirements.
Transitional Support for eCTD v3.2.2
Swissmedic has confirmed that the existing eCTD v3.2.2 format will continue to be supported during a transitional phase lasting several years. 1793080354110
This is particularly important for pharmaceutical companies and regulatory teams managing ongoing dossiers and existing submission systems.
The transition is therefore expected to be gradual rather than immediate.
Swiss Implementation Guide v2.0
The newly released package replaces Version 1.1 and contains updated technical requirements for implementation of eCTD v4.0 in Switzerland.
The package includes:
Implementation Guide (IG) v2.0;
Controlled Vocabulary (CV) v2.0, including Genericode files;
Validation Criteria v2.0. 1793080354110
These documents define the technical framework that software vendors and regulatory submission teams will need to follow when preparing valid Swiss eCTD v4.0 submissions.
Controlled Vocabulary Updates
Controlled Vocabulary plays an important role in ensuring consistent use of defined metadata and submission values.
Version 2.0 includes updated controlled vocabulary lists together with Genericode files, supporting structured implementation within submission software and regulatory systems. 1793080354110
Companies developing or validating publishing tools should therefore review the new package carefully.
Validation Criteria v2.0
The updated package also introduces Validation Criteria v2.0.
These criteria are particularly important because they define the technical checks that submissions must satisfy before being accepted as valid.
Regulatory operations teams and software providers should assess whether their current systems and validation rules need to be updated before the 2027 transition.
Replacement of Version 1.1
The previous Swiss Implementation Guide package, Version 1.1, was published in July 2026.
That version established the technical requirements and served as a basis for software development supporting valid submissions in Switzerland. 1793080354110
Version 2.0 now supersedes that package and should become the primary technical reference for ongoing eCTD v4.0 implementation activities.
Impact on Pharmaceutical Companies
For pharmaceutical companies preparing submissions to Swissmedic, the update is an important milestone in the transition toward eCTD v4.0.
Regulatory teams should consider reviewing:
current eCTD publishing systems;
submission templates;
metadata structures;
controlled vocabulary mappings;
validation processes;
vendor readiness;
internal SOPs;
transition planning from v3.2.2 to v4.0.
Early preparation may help reduce implementation issues once the new standard becomes operational.
Impact on Regulatory Software Vendors
Software vendors supporting Swiss regulatory submissions will also need to align their systems with the updated Swiss Implementation Guide package.
This includes support for:
IG v2.0 requirements;
CV v2.0;
Genericode implementation;
Validation Criteria v2.0;
compatibility with Swissmedic submission infrastructure.
Because the technical implementation is planned for completion by the end of 2026, system readiness will be important ahead of pilot testing and the planned 2027 go-live.
International Harmonisation
Swissmedic states that one of the main goals of the eCTD v4.0 implementation is to improve international compatibility with other regulatory authorities. 1793080354110
For multinational pharmaceutical companies, this may support greater consistency across submission processes in different jurisdictions.
The adoption of the ICH standard also reinforces the broader trend toward harmonised electronic regulatory submissions.
What Companies Should Do Next
Organisations submitting medicinal product applications in Switzerland should begin assessing the new Version 2.0 package now.
Priority actions may include:
comparing Version 2.0 with Version 1.1;
updating regulatory publishing tools;
reviewing controlled vocabulary mappings;
validating software against the new criteria;
planning internal training;
monitoring Swissmedic pilot testing updates;
maintaining readiness for the transition period.
Swissmedic has also indicated that it will continue to provide updates on implementation progress and welcomes feedback on the technical documentation.
