EMA Good Pharmacovigilance Practices (GVP) Modules

The EMA’s GVP Modules are the operational handbook of European pharmacovigilance — formally EU guidance, but treated as international best practice by companies operating globally, regardless of headquarters. Each module covers a specific aspect of safety data collection, assessment, and reporting, and several have been directly reshaped by 2025’s regulatory changes: Module I (Rev 3, 2025) expands QPPV oversight; Module II’s PSMF requirements were amended by Regulation 2025/1466 to document only major or critical deviations; Module IV’s audit requirements were strengthened to make third-party audits mandatory; and Module IX (Rev 2, 2025) formally acknowledges AI-assisted signal management while abolishing standalone health-authority notifications.

The PRAC — the EMA’s Pharmacovigilance Risk Assessment Committee — reviews signals, initiates and reviews PSURs, coordinates benefit-risk assessments, and recommends action to the CHMP. Under Regulation 2025/1466, MAHs are no longer required to send standalone signal notifications to the EMA; signal evaluation is now fully embedded in the PRAC-led process, with MAH assessments submitted through EudraVigilance monitoring and cumulative review rather than separate communications.

For day-to-day work, the GVP Modules function less like a rulebook you read once and more like a reference shelf you return to constantly — a case processor will lean on Module VI for ICSR management, a signal analyst on Module IX, someone drafting an RMP on Module V. Knowing which module governs which activity, and knowing that Module I through XVI aren’t static, is what separates someone reading a PV job description from someone who could actually walk into that role on day one.