eCTD v4.0

From July to September 2020, Swissmedic conducted a public hearing on the Swiss Regional Implementation Guide.

The Implementation Guide is the underlying document describing the technical aspects of the new specifications. It consists of two parts:

o   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;

o   the Swiss Regional Implementation Guide, which was drafted by Swissmedic and contains the technical requirements of the Swiss eCTD module 1.

Swissmedic would like to thank all participants for their comments and feedback. The Implementation Guide will be revised and supplemented in the light of this feedback.

If you have any remarks or questions, please send them to Swissmedic at the coordinates indicated.

Final publication of the Swiss Regional Implementation Guide is scheduled for the end of 2020/beginning of 2021. We will provide further information here in due course.

Swissmedic
Operational Support Services
Hallerstrasse 7
3012 Berne
Switzerland
E-mail

Last modification 22.10.2020

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