eCTD v4.0 is a technical standard developed by the ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) for the submission of authorisation applications for medicinal products. It is an upgraded version of the current eCTD v3.2.2 standard on which Swissmedic’s current eCTD solution is based.
Swissmedic will complete technical implementation of eCTD v4.0 by the end of 2026, after which the standard will go live during 2027 once pilot testing has been completed. The aim is to ensure international compatibility with other regulatory authorities in terms of the requirements for authorisation applications. The current eCTD v3.2.2 standard will initially continue to be supported throughout a transitional phase lasting several years.
Swissmedic will provide continual updates on progress. Suggestions and feedback – particularly concerning the technical documents in the package for the Swiss Implementation Guide – can be submitted through the appropriate contact channels at any time.
News
26.10.2026
Publication of the package for the Swiss Implementation Guide v2.0
Swissmedic is now publishing version 2.0 of the Swiss Implementation Guide package. This version replaces the previously published version 1.1.
The new package contains numerous updates and amendments to the guidance documents.
The package for the Swiss Implementation Guide comprises:
- Implementation Guide (IG) v2.0
- Lists of the required controlled vocabulary (Controlled Vocabulary, CV) v2.0, including the Genericode files
- Validation Criteria v2.0
The documents in question can be downloaded here [LINK].
01.07.2026
Publication of the package for the Swiss Implementation Guide v1.1
Swissmedic is now publishing version 1.1 of the package for the Swiss Implementation Guide. This sets out the technical requirements and serves as a basis for developing software applications for the generation of valid submissions in Switzerland.
The package for the Swiss Implementation Guide comprises:
- Implementation Guide (IG) v1.1
- Lists of the required controlled vocabulary (CV) v1.1
The documents in question can be downloaded here (ZIP, 873 kB, 27.07.2026).
