Regulatory Expectations Pharmacovigilance
Pharmacovigilance Regulatory Expectations
Domain-structured evidence maps outlining what inspectors expect to see during pharmacovigilance inspections. These pages are designed to be citeable, stable, and operationally specific.
Regulatory Expectation Maps (REMs)
| REM | Regulator | PV domain | Lifecycle | Last reviewed |
|---|---|---|---|---|
| MHRA Pharmacovigilance Inspection Expectations — Evidence Map | MHRA | Multi-domain (PV system) | Post-Marketing | 2026-02-23 |
| Literature Surveillance — Regulatory Expectations | Multi-regulator | Literature Surveillance | Post-Marketing | 2026-02-23 |
“Last reviewed” indicates the most recent editorial review against primary regulatory guidance and inspection patterns.
Pharmacovigilance domains
This library is organised by PV domain first. Regulator overlays expand as we publish additional REMs.
Core Operations
- Individual Case Safety Reporting (ICSR) Management
- Signal Management
- Risk Management
- Aggregate Reporting
Governance & Oversight
- Safety Governance & Oversight
- Pharmacovigilance System Master File (PSMF) Management
- Vendor & Partner Management
- Compliance, Quality & Audit
- Training & Competency
- Local Pharmacovigilance (Affiliate PV)
Systems & Interfaces
- Safety Data Management Systems
- Literature Surveillance
- Clinical Safety (Development PV)
- Post-Marketing PV Operations
- Medical Information & PV Interface
- Device & Combination Product Vigilance
- Pharmacovigilance for Special Products
- Benefit–Risk Evaluation
- Regulatory Intelligence & Policy
Common pharmacovigilance inspection triggers
Routine inspections
- Scheduled supervisory inspections
- Risk-based inspection cycles
For-cause inspections
- Delayed, inconsistent, or high-volume ICSRs
- Signal detection concerns or insufficient evaluation evidence
- Major safety changes, urgent safety restrictions, or emerging benefit–risk concerns
- QPPV changes or gaps in oversight evidence
- Licence transfers, M&A, or organisational restructuring affecting PV responsibilities
- Vendor / partner failures or weak oversight evidence
- Regulatory intelligence indicating increased risk of non-compliance
- Complaints, whistleblower reports, or credible external allegations
- Prior critical/major findings and weak CAPA effectiveness evidence
How to use this library
- Start with the PV domain relevant to your inspection scope.
- Open the REM and review the evidence objects inspectors expect to see.
- Compare those expectations to your current SOPs, logs, and governance records.
- Operationalise gaps using the mapped toolkit (masters remain immutable; customers edit their own copies).