Introduction of eCTD v4.0

30. März 2023 – eCTD v4.0 is a technical standard relating to the submission of applications for the authorisation of medicinal products. The standard – developed by the ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) – is an upgraded version of the currently valid standard eCTD v3.2.2 on which Swissmedic’s current eCTD solution is based. Swissmedic will be implementing the new version gradually.

For more information, see here.