Public Review of the new eCTD M1 Specification v1.5


Swissmedic will adapt the eCTD M1 Specification and accordingly carry out a Public Review of the new documents.

The following documents will be updated:

And technical files

For the sake of clarity, you can find all adaptations and changes in a report for comparison with the currently valid Version 1.4.

We look forward to receiving your feedback by 31 January 2020 at