ICH Electronic Common Technical Document (eCTD) v4.0

17 March 2023 – the Swissmedic published eCTD v4.0 Step 4 Implementation Package.

eCTD v4.0 is a technical standard relating to the submission of applications for the authorization of medicinal products. The standard – developed by the ICH (International Council for Harmonization 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.

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