Pharmacovigilance teams must align safety systems, signal detection workflows, and PSUR/DSUR templates with updated EMA guidance. The revisions emphasize earlier identification of emerging risks, improved data-methodologies, and more consistent safety communication — all of which affect regulatory compliance for marketed products in the EU.
Mandate Time Frame
No immediate mandate.
The December 2025 EMA updates are guidance refinements, not new legally binding deadlines.
Agencies typically provide transition flexibility, allowing MAHs to incorporate revised GVP expectations into existing PV systems without a fixed compliance date.
Source
Select Mandate HA
Select Mandate Function