Introduction 

As pharmaceutical companies continue expanding into global markets, pharmacovigilance (PV) professionals are increasingly required to navigate multiple regulatory frameworks simultaneously. While the European Union’s Good Pharmacovigilance Practices (EU GVP) has become a widely recognized benchmark for PV activities, Japan maintains a distinct pharmacovigilance system with unique regulatory requirements, reporting pathways, and post-marketing surveillance expectations. 

For global safety teams, understanding these differences is essential—not only for maintaining regulatory compliance but also for ensuring consistent patient safety across regions. Companies marketing products in both jurisdictions must align global processes while accommodating local requirements, particularly regarding safety reporting, risk management, post-marketing studies, and quality management systems. 

This article compares Japan’s pharmacovigilance system with the EU GVP framework, highlighting the key differences that global pharmacovigilance teams should understand when managing multinational safety operations. 

1. Regulatory Authorities and Legal Framework

European Union 

The European pharmacovigilance system is governed by the European Medicines Agency (EMA) alongside the National Competent Authorities (NCAs) of each Member State. 

The legal basis includes: 

• Regulation (EC) No. 726/2004  

• Directive 2001/83/EC  

• Good Pharmacovigilance Practices (GVP Modules I–XVI)  

The EU follows a harmonized regulatory approach, enabling centralized safety oversight across all Member States through EudraVigilance and standardized GVP guidance. 

Key Characteristics 

• Harmonized legislation across EU Member States  

• Centralized electronic reporting  

• Detailed guidance through GVP modules  

• Strong emphasis on quality systems and risk management  

Japan 

Japan’s pharmacovigilance activities are regulated by: 

• Ministry of Health, Labour and Welfare (MHLW)  

• Pharmaceuticals and Medical Devices Agency (PMDA)  

Unlike the EU, Japan operates under national legislation primarily through: 

• Pharmaceuticals and Medical Devices Act (PMD Act)  

• GPSP (Good Post-marketing Study Practice)  

• GVP Ordinance  

Japan places considerably greater emphasis on post-marketing surveillance and real-world safety monitoring after product approval. 

2. Pharmacovigilance System Structure

EU GVP 

EU GVP requires every Marketing Authorization Holder (MAH) to establish a comprehensive Pharmacovigilance System that includes: 

• Pharmacovigilance System Master File (PSMF)  

• Quality Management System (QMS)  

• Standard Operating Procedures (SOPs)  

• Compliance monitoring  

• Audits  

• Training  

• CAPA management  

The PSMF serves as the central document describing the entire pharmacovigilance system. 

Japan 

Japan requires MAHs to maintain a GVP-compliant quality system focusing on: 

• Organizational structure  

• Safety information collection  

• Safety evaluations  

• Risk minimization activities  

• Post-marketing surveillance  

Unlike the EU, Japan does not require a PSMF equivalent. 

Instead, companies maintain documentation demonstrating compliance with Japanese GVP Ordinance requirements. 

3. Qualified Person Responsibilities

EU: Qualified Person for Pharmacovigilance (QPPV) 

Every MAH must appoint an EU QPPV who is permanently and continuously responsible for the pharmacovigilance system. 

The QPPV oversees: 

• Safety reporting  

• Signal management  

• Risk management plans  

• Regulatory submissions  

• Inspection readiness  

• PSMF maintenance  

• Compliance oversight  

The QPPV must reside and operate within the European Economic Area (EEA). 

Japan: Safety Management Supervisor 

Japan does not have an equivalent QPPV role. 

Instead, MAHs appoint: 

• General Marketing Compliance Officer  

• Safety Management Supervisor  

Responsibilities include: 

• Collection of safety information  

• Evaluation of adverse events  

• Implementation of safety measures  

• Communication with PMDA  

• Oversight of post-marketing surveillance  

The responsibilities are often shared across multiple departments rather than centralized under one individual. 

4. Adverse Event Reporting Requirements

EU 

The EU requires electronic reporting through EudraVigilance. 

Typical reporting timelines include: 

All reports follow the ICH E2B(R3) electronic format. 

Japan 

Japan also follows expedited reporting requirements but distinguishes between domestic and foreign safety information. 

Reporting timelines vary depending on: 

• Seriousness  

• Expectedness  

• Domestic versus foreign occurrence  

• Type of safety concern  

Some events require reporting within: 

• 15 days  

• 30 days  

Japan also requires reporting of important safety findings obtained during post-marketing surveillance activities. 

5. Risk Management

EU 

Risk management is based on the Risk Management Plan (RMP), prepared according to GVP Module V. 

The RMP includes: 

• Safety specification  

• Pharmacovigilance plan  

• Risk minimization measures  

• Additional monitoring  

• Effectiveness evaluation  

RMPs are living documents updated throughout the product lifecycle. 

Japan 

Japan also requires Risk Management Plans. 

However, Japanese RMPs place greater emphasis on: 

• Post-marketing surveillance  

• All-case surveillance (where applicable)  

• Drug use investigations  

• Specific use-results surveys  

• Risk communication to healthcare professionals  

Many newly approved medicines undergo enhanced surveillance activities after launch. 

6. Post-Marketing Surveillance

EU 

Routine pharmacovigilance includes: 

• Signal detection  

• PSUR/PBRER submissions  

• PASS studies  

• Literature monitoring  

• Periodic safety review  

Additional post-authorization studies are conducted when required by regulators. 

Japan 

Post-marketing surveillance is considerably more extensive. 

Common activities include: 

• Drug Use Results Surveys  

• Specific Use Results Surveys  

• Post-marketing Clinical Studies  

• All-Case Surveillance  

• Early Post-Marketing Phase Vigilance (EPPV)  

EPPV is a distinctive Japanese requirement involving intensive safety monitoring during the first six months after product launch. 

7. Periodic Safety Reporting

EU 

The EU requires submission of: 

• Periodic Safety Update Reports (PSURs) following ICH E2C(R2)  

• EU Reference Dates (EURD) list compliance  

• Benefit-risk evaluation  

• Signal assessment  

• Worldwide cumulative data  

Submission schedules are coordinated centrally across Europe. 

Japan 

Japan also accepts ICH-aligned PBRERs for many products. 

However, additional Japanese-specific safety summaries or periodic reports may be requested depending on: 

• Product type  

• Approval conditions  

• Re-examination period  

• PMDA requirements  

8. Inspections and Compliance

EU 

EMA and national authorities conduct pharmacovigilance inspections evaluating: 

• QMS effectiveness  

• PSMF  

• SOP implementation  

• Vendor oversight  

• Training records  

• Signal management  

• CAPA effectiveness  

Critical findings may lead to regulatory action. 

Japan 

PMDA inspections focus heavily on: 

• Compliance with GVP Ordinance  

• GPSP requirements  

• Safety information management  

• Post-marketing surveillance  

• Documentation  

• Organizational responsibilities  

Inspection readiness requires maintaining complete and well-documented safety processes. 

9. Practical Considerations for Global Safety Teams

Organizations operating in both regions should avoid assuming that compliance with EU GVP automatically satisfies Japanese regulatory expectations. 

Successful global pharmacovigilance programs typically: 

• Develop global SOPs with country-specific appendices.  

• Clearly define regional roles and responsibilities.  

• Maintain separate reporting workflows where required.  

• Incorporate Japan-specific post-marketing surveillance activities into global safety plans.  

• Ensure local regulatory expertise is available during inspections and audits.  

• Align global quality systems while preserving compliance with regional requirements.  

Understanding these regional nuances allows organizations to maintain consistent patient safety standards while meeting local regulatory obligations. Achieving this requires pharmacovigilance systems that can balance global standards with local requirements. Through its pharmacovigilance services, Baupharma helps pharmaceutical companies build and maintain compliant safety processes that support effective risk management and patient safety worldwide. 

Key Takeaways 

• The EU pharmacovigilance system is built around the EMA, EU GVP modules, the QPPV, and the PSMF.  

• Japan’s pharmacovigilance system is regulated by the MHLW and PMDA under the PMD Act, GVP Ordinance, and GPSP.  

• Japan places significantly greater emphasis on post-marketing surveillance, including Drug Use Results Surveys, All-Case Surveillance, and Early Post-Marketing Phase Vigilance (EPPV).  

• The EU requires a Qualified Person for Pharmacovigilance (QPPV), while Japan assigns safety responsibilities through organizational roles such as the Safety Management Supervisor.  

• Although both regions follow ICH principles for safety reporting, reporting timelines, documentation requirements, and regulatory expectations differ.  

• Global safety teams should adopt harmonized processes while integrating country-specific procedures to ensure compliance across both jurisdictions.