Vigilance and safety

Pharmacovigilance and signal management

GVP separates pharmacovigilance processes into modules. Module III inspection revision 2 is effective from 10 September 2026. EMA also identifies upcoming updates linked to E2D(R1) and M14.

Sources and scope checked: 3 October 2026 · Guide version 1

Scope: Reporting routes and deadlines are jurisdiction-specific; this note’s date is not every module’s effective date.

View my progress Practise in the lab

Prepare your evidence before a decision

Mark the prompts for which you have organised evidence. Completion tracks preparation; it does not establish product or site compliance.

Identify report type, authority and data-protection requirements.
Distinguish an individual report from a signal and causality assessment.
Record missing information and follow-up actions.
Check the applicable version and local escalation procedures.

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Pharmacovigilance and signal management

Prepare your evidence before a decision

Continue to practice