EudraVigilance (European Union Drug Regulating Authorities Pharmacovigilance) is the European data processing network and management system for reporting and evaluation of suspected
adverse reactions to medicines which have been authorised or being studied in clinical trials in the
European Economic Area
The European Economic Area (EEA) was established via the ''Agreement on the European Economic Area'', an international agreement which enables the extension of the European Union's single market to member states of the European Free Trade Ass ...
(EEA). The European Medicines Agency (EMA) operates the system on behalf of the European Union (EU) medicines regulatory network.
The European EudraVigilance system deals with the:
* Electronic exchange of Individual Case Safety Reports (ICSR, based on the
ICH
Ich may refer to:
* Ich, a German pronoun meaning ''I'', also a Middle English form of ''I''
* The ego, one of the psychic apparatus defined in Sigmund Freud's structural model of the psyche
* ''Ich'' (album), an album by German rapper Sido
* I ...
E2B specifications):
** EudraVigilance Clinical Trial Module (EVCTM) for reporting Suspected Unexpected Serious Adverse Reactions (
SUSARs).
** EudraVigilance Post-Authorisation Module (EVPM) for post-authorisation ICSRs.
* Early detection of possible safety signals from marketed drugs for human use.
[CIOMS Working Group VIII. Practical aspects of signal detection in pharmacovigilance. Geneva: Council for International Organizations of Medical Sciences; 2010]
* Continuous monitoring and evaluation of potential safety issues in relation to reported adverse reactions.
* Decision-making process, based on a broader knowledge of the adverse reaction profile of drugs.
EMA publishes data from EudraVigilance in the European database for suspected adverse drug reactio
reports
The EudraVigilance access policy governs the level of access different stakeholder groups have to adverse drug reaction
reports
See also
*
Clinical trial
Clinical trials are prospective biomedical or behavioral research studies on human subject research, human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel v ...
*
Drug development
Drug development is the process of bringing a new pharmaceutical drug to the market once a lead compound has been identified through the process of drug discovery. It includes preclinical research on microorganisms and animals, filing for r ...
*
EudraCT
*
EudraGMP
*
EudraLex
*
EUDRANET
*
EudraPharm
*
European Clinical Research Infrastructures Network
*
European Medicines Agency
*
International Society of Pharmacovigilance The International Society of Pharmacovigilance (ISoP), previously the European Society of Pharmacovigilance (ESOP), is an international non-profit scientific organisation, which aims to foster pharmacovigilance both scientifically and educationally, ...
*
Medication
A medication (also called medicament, medicine, pharmaceutical drug, medicinal drug or simply drug) is a drug used to diagnose, cure, treat, or prevent disease. Drug therapy ( pharmacotherapy) is an important part of the medical field an ...
*
Pharmacovigilance
Term Given By Tushar Sharma (UPES Batch 2025)
Pharmacovigilance (PV, or PhV), also known as drug safety, is the pharmaceutical science relating to the "collection, detection, assessment, monitoring, and prevention" of adverse effects with phar ...
*
Serious adverse event A serious adverse event (SAE) in human drug trials is defined as any untoward medical occurrence that at any dose
#Results in death
#Is life-threatening
#Requires inpatient hospitalization or causes prolongation of existing hospitalization
#Resul ...
*
Uppsala Monitoring Centre
Uppsala Monitoring Centre (UMC), located in Uppsala, Sweden, is the field name for the World Health Organization Collaborating Centre for International Drug Monitoring. UMC works by collecting, assessing and communicating information from member ...
*
Yellow Card Scheme
The Yellow Card Scheme is the United Kingdom's system for collecting information on suspected adverse drug reactions (ADRs) to medicines. The scheme allows the safety of the medicines and vaccines that are on the market to be monitored.
History ...
References
External links
EudraVigilance
European clinical research
Pharmaceuticals policy
Health and the European Union
Drug safety
National agencies for drug regulation
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