Regulatory Expectations
Pharmacovigilance regulatory expectations
Understand the evidence, controls, and oversight regulators expect across core pharmacovigilance activities.
Find the expectation closest to your question
Each topic explains what regulators expect, why it matters, what can go wrong, and what teams should be able to show.
What Do Inspectors Check for Pharmacovigilance Literature Surveillance?
MAHs are expected to monitor appropriate medical and scientific literature using a defined, risk-based schedule and a justified source list.
View topicWhat Do Inspectors Check in Pharmacovigilance Literature Search Strategies?
Inspectors expect literature search strategies to be documented, reproducible, and capable of identifying relevant safety information.
View topicWhat Do Inspectors Check for Pharmacovigilance KPI Governance and Oversight?
Pharmacovigilance systems should monitor operational performance through defined KPIs aligned with regulatory obligations.
View topicWhat Do Inspectors Check for Pharmacovigilance KPI Design and Metric Selection?
Pharmacovigilance systems should define KPIs that monitor operational performance and regulatory compliance.
View topicWhat Do Inspectors Check for Pharmacovigilance KPI Monitoring and Dashboards?
Pharmacovigilance systems should monitor performance through structured KPI dashboards and reporting tools.
View topicWhat Do Inspectors Check for Pharmacovigilance KPI Review Meetings and Oversight?
Pharmacovigilance systems should review KPI performance through structured governance meetings.
View topicWhat Do Inspectors Check for Pharmacovigilance KPI Escalation and CAPA?
KPI deviations must trigger escalation, investigation, and corrective action within the pharmacovigilance system.
View topicWhat Do Inspectors Check for ICSR Case Management Requirements?
Pharmacovigilance systems must manage ICSRs through a structured, end-to-end process from receipt to closure.
View topicWhat Do Inspectors Check for ICSR Case Intake and Source Management?
All safety information must be captured through defined intake processes.
View topicWhat Do Inspectors Check for ICSR Case Data Entry and Quality Control?
ICSR data must be entered completely, accurately, and consistently into the safety database.
View topicWhat Do Inspectors Check for ICSR Medical Review and Assessment?
ICSRs must undergo medical review by a qualified professional.
View topicWhat Do Inspectors Check for ICSR Reporting Timelines and Submission?
ICSRs must be reported to regulatory authorities within defined timelines.
View topicWhat Do Inspectors Check for Safety Data Exchange Agreement Requirements?
Pharmacovigilance responsibilities shared between companies or service providers must be governed by a defined Safety Data Exchange Agreement.
View topicWhat Do Inspectors Check for Safety Data Exchange Agreement Roles and Responsibilities?
Safety Data Exchange Agreements must define roles and responsibilities clearly for all pharmacovigilance activities covered by the relationship.
View topicWhat Do Inspectors Check for Safety Data Exchange Timelines and Compliance?
Safety Data Exchange Agreements must define clear timelines for exchanging valid cases, follow-up information, and other safety data.
View topicWhat Do Inspectors Check for Safety Data Exchange Reconciliation and Data Consistency?
Safety Data Exchange Agreements must require routine reconciliation of safety data between the parties.
View topicWhat Do Inspectors Check for Vendor Oversight and Governance in Pharmacovigilance?
The MAH must retain ultimate responsibility for pharmacovigilance even when activities are outsourced.
View topicWhat Do Inspectors Check for Vendor Qualification Requirements in Pharmacovigilance?
Pharmacovigilance vendors must be formally qualified before performing safety activities, ensuring they have the systems, expertise, and compliance...
View topicWhat Do Inspectors Check for Vendor Due Diligence and Risk Assessment in Pharmacovigilance?
Pharmacovigilance vendors must undergo documented due diligence before engagement.
View topicWhat Do Inspectors Check for Vendor Selection and Approval Process in Pharmacovigilance?
Pharmacovigilance vendors must be selected through a structured and documented evaluation process.
View topicWhat Do Inspectors Check for Vendor Performance Monitoring in Pharmacovigilance?
Pharmacovigilance vendors must be monitored continuously using defined performance metrics.
View topicWhat Do Inspectors Check for Vendor Requalification and Lifecycle Management in Pharmacovigilance?
Pharmacovigilance vendors must be periodically requalified to confirm continued suitability.
View topicWhat Do Inspectors Check for Pharmacovigilance Roles and Responsibilities Framework?
Pharmacovigilance systems must define clear roles and responsibilities across all activities.
View topicWhat Do Inspectors Check for QPPV Responsibilities and Oversight?
The QPPV is ultimately responsible for the pharmacovigilance system and its compliance.
View topicMove from expectation to working control
Browse the post-market safety toolkits that help teams turn pharmacovigilance responsibilities into owned procedures, records, evidence, and oversight.