· CORE DISCIPLINE
GVP

Good Pharmacovigilance Practice

Safety surveillance, signal management, and adverse-event reporting.

Browse all 11 GVP standards →Assess your quality system →

What this page does not claim

Educational orientation — not a determination of regulatory applicability, compliance, validation scope, or organizational approval.

WHAT IT GOVERNS

Good Pharmacovigilance Practice governs how the safety of medicines is monitored once they are on the market (EU GVP Modules and equivalents) — collecting, assessing, and acting on adverse-event and signal data to protect public health across the entire product lifecycle. It is the discipline that keeps a licensed product’s benefit–risk balance under continuous review.

WHY IT MATTERS

Pre-approval trials cannot surface every rare or long-latency risk; post-market surveillance is where those signals actually emerge. Late detection or a reporting failure can cost lives and a marketing authorization, and pharmacovigilance findings routinely trigger regulatory action. GVP is the safety net for the whole marketed portfolio.

KEY FOCUS AREAS

01

Adverse-event collection & reporting

Capturing individual case safety reports from every source and reporting them to authorities within defined timelines — the raw material of safety surveillance.

02

Signal management

Detecting, validating, assessing, and acting on safety signals — turning a scatter of case reports into a substantiated change in what is known about a medicine.

03

The PSMF & QPPV

A Pharmacovigilance System Master File that describes the system, and a Qualified Person for Pharmacovigilance accountable for its operation and oversight.

04

Risk management plans (RMPs)

Documented risk-minimisation and pharmacovigilance activities proportionate to a product’s risks, kept current as the safety profile evolves.

STANDARDS SPEQ DECODES · 11

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EU GVP ModulesEMAHIGH INSPECTION RISK
EU Good Pharmacovigilance Practices (GVP)
21 CFR 314.80FDAHIGH INSPECTION RISK
Postmarketing Reporting of Adverse Drug Experiences
ICH E2B(R3)ICH
Electronic Transmission of Individual Case Safety Reports (ICSRs)
ICH E2AICH
Clinical Safety Data Management: Definitions and Standards for Expedited Reporting
21 CFR Part 803FDAHIGH INSPECTION RISK
Medical Device Reporting (MDR)
ICH E2C(R2)ICHHIGH INSPECTION RISK
Periodic Benefit-Risk Evaluation Report (PBRER)
ICH E2D(R1)ICH
Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports
Reg. (EU) 520/2012ECHIGH INSPECTION RISK
Commission Implementing Regulation on the Performance of Pharmacovigilance Activities
21 CFR 600.80FDAHIGH INSPECTION RISK
Postmarketing Reporting of Adverse Experiences (Biological Products)
VICH GL24VICH
Pharmacovigilance of Veterinary Medicinal Products: Management of Adverse Event Reports (AERs)
ICH E2EICH
Pharmacovigilance Planning

WHAT INSPECTORS LOOK AT

  • Case processing quality and reporting timeliness (expedited and periodic)
  • Signal detection, evaluation, and the actions taken from it
  • Currency and accuracy of the Pharmacovigilance System Master File
  • The QPPV’s oversight and access to the full safety system

KEY REGULATORY BODIES

Derived from the 11 standards SPEQ decodes for this discipline.

RELATED DISCIPLINES

GCPGood Clinical PracticeQMSQuality Management SystemsGDocPGood Documentation Practice

SECTORS THAT OPERATE UNDER GVP

CROCROs & Contract ResearchSponsors / MAHSponsors & Marketing Authorization HoldersClinical SitesClinical Trial Sites
TOPIC EXPLAINERS ACROSS THIS DISCIPLINE
14 total
Pharmacovigilance Signal Management →
How a safety signal is detected, validated, assessed, and acted on — the GVP process that turns individual case reports into a change to a medicine’s benefit-risk balance.
Informed Consent & Ethics Oversight →
The two structural safeguards that make a clinical trial ethical — independent ethics review before it starts, and a genuine informed-consent process for every participant — and why consent is a process, not a signature.
Periodic Safety Reporting: PSURs & PBRERs →
The scheduled aggregate safety reports through which a marketing-authorisation holder periodically re-evaluates a medicine’s benefit-risk balance — the periodic complement to continuous signal management.
ICSRs & Expedited Reporting →
The atomic unit of pharmacovigilance and the clock attached to it — the four things that make a case valid, why "serious" is not "severe", and what actually triggers a 15-day report.
QPPV & the Pharmacovigilance System Master File →
The named human who is personally accountable for a company’s safety system, and the single document that describes it — why the EU built pharmacovigilance around a person and a map, not just processes.
Literature Monitoring in Pharmacovigilance →
The scientific literature is a legally-mandated source of adverse-event cases — a systematic, documented search with defined databases and a weekly rhythm, not an occasional look.
RMP vs REMS: EU & US Risk Management →
The EU requires a risk management plan for essentially every new medicine; the US imposes a REMS only when a specific safety problem demands it — a default-on system versus an exception-based one.
The EU Risk Management Plan (RMP) →
The structure of the EU-RMP — safety specification, pharmacovigilance plan, risk-minimisation — and how it evolves across a product’s life.
Additional Monitoring & Black Triangle →
The inverted black triangle, the EU additional-monitoring list, and why "▼" means report every suspected reaction.
PV Audits & Inspections →
How the PV system is assured — risk-based internal audit, the CAPA loop, and what a GVP inspection actually examines.
Safety Governance & Benefit-Risk →
Benefit-risk changes as evidence accumulates — and where safety governance reports into commercial ownership, the structure itself is a finding.
Postauthorisation Studies & Real-World Evidence →
Real-world data were collected for another purpose — whether they can support the question is a judgement that must be made explicitly.
Medical Information & Inquiry Handling →
A high-volume front door through which adverse events and complaints arrive disguised as questions.
Safety Systems & Partner Data Exchange →
Every exchange with a partner is a place a case can be delayed or lost — and reconciliation only works if it is periodic and two-way.

GVP: frequently asked questions

Reference answers on Good Pharmacovigilance Practice — what it governs, what regulations define it, and what it requires.

What is Good Pharmacovigilance Practice (GVP)?

GVP governs how the safety of medicines is monitored once they are on the market — collecting, assessing, and acting on adverse-event and signal data to protect public health across the product lifecycle. It is the discipline that keeps a licensed product’s benefit–risk balance under continuous review.

What defines GVP requirements?

In the EU, pharmacovigilance requirements are set out in the Good Pharmacovigilance Practices (GVP) Modules published by the European Medicines Agency, alongside equivalent national frameworks. They cover adverse-event reporting, signal management, risk management plans, and the Pharmacovigilance System Master File.

What are the PSMF and the QPPV?

The Pharmacovigilance System Master File (PSMF) is the document that describes a company’s pharmacovigilance system. The Qualified Person for Pharmacovigilance (QPPV) is the individual accountable for the operation and oversight of that system, with access to the full safety data it holds.

THE FRAMEWORK

How SPEQ maps this discipline across the three layers →

FDA QMM

The maturity of the quality system behind this discipline →