Swissmedic: Supplement to the Guidance Document on PSUR Signal Management TAM

1 November 2025

Swissmedic has added a supplement to the Guidance Document on PSUR Signal Management TAM. The amendment concerns annual reports from the Signal Management Process in the EU. These annual reports cannot be submitted as a substitute for a PSUR, as they do not meet the minimum content requirements of a periodic report.

For more information, see here.