eCTD v4.0 is a new 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. The new standard will be introduced over the next few years; the exact timeframe has not yet been defined.
In connection with the introduction of the new eCTD v4.0 standard, Swissmedic is conducting a public consultation of the Swiss Regional Implementation Guide and the related technical documents. 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 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.
The public consultation relates to the Swiss regional Implementation Guide.
In launching this public consultation process, Swissmedic is inviting authorisation holders, software manufacturers, service providers in the regulatory affairs field, other authorities and interested parties to examine the current Implementation Package and communicate their comments and change requests to Swissmedic. Please use the form provided to send Swissmedic your feedback by 30 September 2020.
Comments arising from the public consultation will be used to optimise the Implementation Package. In this way, we can create the right basis for successfully rolling out the new eCTD v4.0 standard at Swissmedic and other relevant organisations. The final Implementation Package is due to be published in December 2020.
The Swiss Implementation Package contains the following files:
- draft Swiss eCTD v4.0 Implementation Guide
- lists of all Controlled Vocabularies
- template for comments submitted in the public consultation