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 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 participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietar ...
*
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 re ...
*
EudraCT
EudraCT (European Union Drug Regulating Authorities Clinical Trials) is the European clinical trials registry, Clinical Trials Database of all clinical trials of investigational medicinal products with at least one site in the European Union commen ...
*
EudraGMP EudraGMP is the database of the European Community of manufacturing authorisations and of certificates of good manufacturing practice. The EudraGMP system was launched in April 2007, for use by European Medicines Regulators. Access for the general ...
*
EudraLex
EudraLex is the collection of rules and regulations governing medicinal products in the European Union.
Volumes
EudraLex consists of 10 volumes:
*Concerning Medicinal Products for Human use:
**Volume 1 - Pharmaceutical Legislation.
**Volume 2 - ...
*
EUDRANET EUDRANET, the European Telecommunication Network in Pharmaceuticals (European Union Drug Regulating Authorities Network), is an IT platform to facilitate the exchange of information between regulatory partners and industry during submission and eval ...
*
EudraPharm
EudraPharm (European Union Drug Regulating Authorities Pharmaceutical Database) was the database of medicinal products authorised in the European Union, and included the information contained in the Summary of Product Characteristics, the patient ...
*
European Clinical Research Infrastructures Network
The Framework Programmes for Research and Technological Development, also called Framework Programmes or abbreviated FP1 to FP9, are funding programmes created by the European Union/European Commission to support and foster research in the Europea ...
*
European Medicines Agency
The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of medicinal products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or Euro ...
*
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 and re ...
*
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 pharma ...
*
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
#Results ...
*
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 c ...
*
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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