What has changed?

The structure of the guidance has been fundamentally revised to ensure better clarity and readability. In our opinion, the most important changes include:

For regulatory signals without serious risk potential, the initial notification is no longer required. In addition, day 0 for signals and results from EMA PSUR/PSUSA procedures has been redefined. The reporting deadline for regulatory signals without serious risk potential has been extended from 30 to 90 days.
Requests for adjustments to drug information should no longer be submitted at the same time as the signal report, as risk-minimizing measures from regulatory signals will in future be implemented in full as part of the signal procedure.
The publication deadline for the updated drug information texts is now linked to the completion of the Type IAIN request and is no later than 20 days after its completion.

The amended guidelines will be valid from February 1, 2026.

Changes to the Guidance document Drug Safety Signals HMP and the Signal Notification Form

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