EudraVigilance
The European Medicines Agency's central database for adverse drug reaction reporting across the EU
EudraVigilance is the European Medicines Agency's (EMA) centralised database for adverse drug reaction (ADR) reports from across the European Union. It serves as the primary pharmacovigilance infrastructure for the EU's 27 member states, enabling coordinated signal detection and regulatory response at a pan-European level.
Key Facts
Coverage
Covers all 27 EU member states plus EEA countries (Iceland, Liechtenstein, Norway). All nationally authorised and centrally authorised medicines including vaccines are monitored.
Management
Operated by the European Medicines Agency (EMA) in Amsterdam. EMA's Pharmacovigilance Risk Assessment Committee (PRAC) reviews safety signals identified in EudraVigilance.
Public Access
The European database of suspected adverse drug reactions (www.adrreports.eu) provides public access to aggregated ADR data for all medicines with EU marketing authorisation.
Regulatory Integration
EudraVigilance data directly informs PRAC assessments, European Public Assessment Reports (EPARs), and regulatory decisions including label updates and market withdrawals.
How EudraVigilance Works
- Marketing authorisation holders (pharmaceutical companies) are required to submit all serious adverse event reports within 15 days
- National competent authorities in each member state submit reports from healthcare professionals and patients
- EMA's PRAC reviews signals identified through automated signal detection and individual case review
- Signals with EU-wide implications trigger coordinated assessment across all member states
- Outcomes may include label updates, risk minimisation measures, or referral procedures
Role in COVID-19 Vaccine Safety
- Identified the Thrombosis with Thrombocytopenia Syndrome (TTS) signal with the AstraZeneca COVID-19 vaccine in March 2021 — leading to regulatory restrictions
- Monitored myocarditis/pericarditis signal for mRNA vaccines — coordinated with FDA and other agencies globally
- Enabled rapid cross-country comparison of adverse event rates across the EU during mass vaccination rollout
- PRAC conducted multiple safety reviews resulting in updated product information
Limitations
- Mandatory reporting applies to serious events — non-serious events may be underreported
- Quality and completeness of reports vary by country and healthcare system
- Signal detection algorithms can generate false positives requiring clinical validation
- Data not publicly available at individual case level due to privacy regulations
Sources & Citations
EMA. "EudraVigilance." European Medicines Agency. https://www.ema.europa.eu/en/human-regulatory/overview/pharmacovigilance/eudravigilance
EMA. "European database of suspected adverse drug reaction reports." https://www.adrreports.eu
EMA. "Pharmacovigilance Risk Assessment Committee (PRAC)." European Medicines Agency. https://www.ema.europa.eu/en/committees/pharmacovigilance-risk-assessment-committee-prac
EMA. "COVID-19 vaccine safety updates." European Medicines Agency. https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/coronavirus-disease-covid-19/treatments-vaccines/vaccines-covid-19/safety-covid-19-vaccines