EudraVigilance is the EU’s centralized database for reporting and evaluating suspected ADRs. It serves:
- Healthcare Professionals (HCPs) and patients to report side effects.
- Marketing Authorization Holders (MAHs) and National Competent Authorities (NCAs) to monitor drug safety.
- Regulatory bodies to identify emerging risks and take corrective actions.
The system aligns with the EU Pharmacovigilance Legislation (2010), ensuring compliance with Good Pharmacovigilance Practices (GVP).
- Who Can Report Adverse Events?
- Healthcare Professionals: Doctors, pharmacists, nurses.
- Patients/Consumers: Direct reporting via national portals.
- Marketing Authorization Holders (MAHs): Legally obligated to submit ADRs.
- National Competent Authorities (NCAs): Submit reports from their regions.
- Step-by-Step Reporting Process
Step 1: Detection of an Adverse Event
- An HCP or patient identifies a suspected ADR linked to a medicine.
- Example: A patient experiences severe dizziness after starting a new anticoagulant.
Step 2: Data Collection
Reporters must gather:
- Patient demographics (age, gender, anonymized).
- Suspect medicine(s): Name, dose, batch number, administration route.
- Adverse event details: Description, onset date, severity, outcome.
- Medical history: Concomitant medications, pre-existing conditions.
Step 3: Submission via EudraVigilance
- Electronic Reporting:
- Reports are submitted as Individual Case Safety Reports (ICSRs) in the ICH E2B(R3) format.
- Healthcare professionals/patients: Use national reporting systems (e.g., UK’s Yellow Card Scheme, Germany’s BfArM), which feed into EudraVigilance.
- MAHs: Submit directly via the EudraVigilance Gateway using the EVWEB tool.
- Manual Reporting:
- In rare cases, paper forms are accepted, but electronic submission is strongly encouraged.
Step 4: Data Validation
- Automated checks ensure completeness and validity (e.g., valid medicinal product identifier, MedDRA coding for ADR terms).
- Duplicate reports are flagged using algorithms to avoid data redundancy.
Step 5: Data Analysis and Signal Detection
- The EMA and NCAs use the EudraVigilance Data Analysis System (EVDAS) to:
- Identify potential safety signals (unexpected or increased ADRs).
- Perform statistical analyses (e.g., disproportionality measures).
- Signals are reviewed by the Pharmacovigilance Risk Assessment Committee (PRAC).
Step 6: Regulatory Action
- If a risk is confirmed, actions may include:
- Updating product labels (SmPC).
- Restricting use.
- Issuing Direct Healthcare Professional Communications (DHPCs).
- Product withdrawal in extreme cases.
- Key Features of EudraVigilance
- EudraVigilance Medicinal Product Dictionary (EVMPD): Standardizes product names and ingredients.
- XEVMPD (Extended EudraVigilance Product Report): Tracks authorized medicines in the EU.
- EudraVigilance Gateway: Secure platform for ICSR exchange between MAHs, NCAs, and EMA.
- Compliance and Timelines
- MAHs must report:
- Serious ADRs: Within 15 days (7 days for expedited reports).
- Non-serious ADRs: Within 90 days.
- Patients/HCPs: No strict deadlines, but prompt reporting is encouraged.
- Challenges in EudraVigilance Reporting
- Underreporting: Lack of awareness among patients/HCPs.
- Data Quality: Incomplete or inconsistent entries.
- Global Harmonization: Aligning with other systems (e.g., FDA’s FAERS, WHO’s VigiBase).
- Recent Enhancements
- ICH E2B(R3) Implementation: Improved data granularity and structured coding.
- Enhanced Patient Reporting: User-friendly portals (e.g., EMA’s “Report a Side Effect” portal).
- AI Integration: Machine learning for faster signal detection.
- Importance of EudraVigilance
- Protects public health by enabling rapid risk identification.
- Supports evidence-based regulatory decisions.
- Strengthens trust in medicines through transparency (public access to ADR data via EudraVigilance Public Website
