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In Japan, GVP (Good Vigilance Practice) is a regulatory framework that governs how pharmaceutical companies monitor, assess, and report drug safety after approval.

Mandated under the Pharmaceuticals and Medical Devices Act (PMD Act) and enforced by PMDA, GVP ensures that Marketing Authorization Holders (MAH/DMAH) maintain robust pharmacovigilance systems throughout the product lifecycle.

What Does GVP Cover?

GVP focuses on:

  • Adverse event collection and reporting
  • Signal detection and risk evaluation
  • Safety database management
  • Periodic safety reporting to PMDA
  • Implementation of risk minimization measures

In simple terms:
GVP ensures ongoing drug safety after approval.

Key Requirements Under GVP

Companies must establish:

  • A qualified pharmacovigilance system
  • Defined SOPs and reporting workflows
  • Timely submission of safety reports
  • Continuous risk-benefit evaluation
  • Inspection readiness for PMDA audits

Why GVP Matters

With increasing scrutiny from PMDA, GVP compliance is critical to:

  • Maintain product approvals
  • Avoid regulatory findings
  • Ensure patient safety
  • Support lifecycle management

The Bottom Line

GVP is not just a compliance requirement—it is a continuous commitment to safety and regulatory excellence in Japan.