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. In a first step, the Implementation Guide that forms the basis for technical implementation is being published. The next step will see the preparation of the technical infrastructure required for Swissmedic to receive and review applications according to eCTD v4.0. During the transition period, which has yet to be defined but will last for several years, it will be possible to make submissions according to both standards.
Publication of the Swiss Implementation Guide v1.0
The Implementation Guide is the underlying document describing the technical aspects of the new specifications. It consists of two parts:
- The ICH Implementation Guide, which was developed by the ICH and relates to the internationally harmonised eCTD modules 2–5 and to the overarching topics. This Guide was first published in 2015 and has been successively updated ever since;
- The Swiss Regional Implementation Guide, which was drafted by Swissmedic and contains the technical requirements of the Swiss eCTD module 1.
- Both documents together set out the requirements under the new eCTD solution.
The package for the Swiss Implementation Guide includes:
- Implementation Guide (IG) v1.0
- Lists containing the required controlled vocabulary (CV)
- Context of Use v1.0
- Submission Type v1.0
- Submission Unit Type v1.0
The package can be downloaded at this address (ZIP, 643 kB, 17.03.2023).
Swissmedic will provide information on the further steps in implementing the new standard here.
If you have any remarks or questions, please send them to Swissmedic at the coordinates indicated.