EudraVigilance: EU adverse reaction database
EudraVigilance is the EU system for collecting, managing and analysing suspected adverse reaction reports for medicines authorised in the EEA.
Article 24 of Regulation (EC) No 726/2004 requires EMA, with the Member States and the Commission, to run a data processing network and database for pharmacovigilance information, and Articles 107 and 107a of Directive 2001/83/EC make it the single point of reporting. Since 22 November 2017 marketing authorisation holders submit individual case safety reports (ICSRs) only to EudraVigilance, which forwards them to the national competent authority of the Member State where the reaction occurred. Holders must also monitor the database for their own substances, using the EudraVigilance Data Analysis System (EVDAS) and the electronic reaction monitoring reports it generates.
The system has two parts: the post-authorisation module for ICSRs from spontaneous reports, literature and post-authorisation studies, and the clinical trial module for suspected unexpected serious adverse reactions from interventional trials. Reports are exchanged in the ICH E2B(R3) format. The Article 57 database of authorised products sits alongside it and supplies the product and substance data that case reports are coded against. Each holder needs a registered organisation, a headquarters user and a QPPV or responsible person who manages access.
Monitoring duties come from GVP Module IX on signal management. Holders must review the reports concerning their active substances, assess any signal and inform EMA and the national authorities of validated signals. Since the 2017 relaunch holders no longer receive ICSRs forwarded from authorities; they are expected to download them from EudraVigilance instead, which changed how many pharmacovigilance databases are reconciled.
What goes wrong: late submission because a case was first processed as non-serious and then upgraded on medical review, with the 15-day clock counted from the upgrade rather than from first receipt; duplicates created when a case reaches the holder through a partner and through a literature search; follow-up information filed as a new case; a QPPV registration that lapses when staff leave, so nobody can access EVDAS; and unresolved negative acknowledgements that mean a case was never actually received. Inspectors check reconciliation between the holder's safety database and EudraVigilance, so unexplained differences are a common finding, as is a literature screening process that never reaches the case entry step in time.
Timing
Serious suspected adverse reactions occurring in the EU or in third countries must be submitted within 15 days of the holder becoming aware of them. Non-serious reactions occurring in the EU must be submitted within 90 days. The clock starts on day zero, the day any member of the holder's organisation first receives the minimum information for a valid case.
Used in
Pharmacovigilance and regulatory teams turn reporting and monitoring duties into owned tasks in the obligation-to-action workflow.
Related terms
- xEVMPD: extended EudraVigilance medicinal product dictionary (Article 57 database)The xEVMPD, or Article 57 database, is EMA's record of every medicine authorised in the EU, which holders must keep updated within 15 days of changes.
- Signal detection: identifying new safety information from pharmacovigilance dataSignal detection is the process of finding information that suggests a new or changed causal link between a medicine and an adverse event.
- QPPV: qualified person responsible for pharmacovigilanceThe QPPV is the named individual, resident in the EU, who is personally responsible for a marketing authorisation holder's pharmacovigilance system.
- PSMF: pharmacovigilance system master fileThe pharmacovigilance system master file (PSMF) is the holder's detailed description of its pharmacovigilance system, kept in the EU for inspectors.
- PSUR: periodic safety update reportA periodic safety update report (PSUR) is a holder's periodic benefit-risk evaluation of a medicine, due at intervals set by the EURD list or the MA.
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