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 (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
* ...
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
*
EudraCT
EudraCT (European Union Drug Regulating Authorities Clinical Trials) is the European Clinical Trials Database of all clinical trials of investigational medicinal products with at least one site in the European Union commencing 1 May 2004 or later. ...
*
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
*
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
*
European Medicines Agency
*
International Society of Pharmacovigilance
*
Medication
A medication (also called medicament, medicine, pharmaceutical drug, medicinal drug or simply drug) is a drug used to medical diagnosis, diagnose, cure, treat, or preventive medicine, prevent disease. Drug therapy (pharmacotherapy) is an imp ...
*
Pharmacovigilance
*
Serious adverse event
*
Uppsala Monitoring Centre
*
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
{{health-stub