EudraVigilance

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EudraVigilance ( E uropean U nion D rug R egulating A uthorities Pharmaco vigilance ) is an information network and management system , which as a central service of the European Medicines Agency is operated with the goal of a safe drug application in the European economic area .

EudraVigilance serves in particular

  • the electronic transmission of reports on side effects before and after the approval of a drug (including suspected cases) and their systematic collection in a common European database
  • the provision of this information in varying degrees for different user groups (authorities, public, pharmaceutical industry)
  • the detection of drug risks

Components

EudraVigilance has several components.

  • The EudraVigilance Database Management System (EVDBMS) is the core of the European pharmacovigilance database. It enables the standardized, electronic and automated data transmission of security-relevant information and consists of two modules:
  1. The " Clinical Trial Module " ( EudraVigilance Clinical Trial Module , EVCTM) is designed to record reports of suspected unexpected serious adverse reactions (SUSARs) in clinical studies
  2. The “Postmarketing Module” ( EudraVigilance Post-Authorization Module , EVPM) is used to record reports ( Individual Case Safety Reports , ICSRs) from non-interventional studies and spontaneous reports
  • The Extended EudraVigilance Medicinal Product Dictionary (XEVMPD) is a new, extended version of the July 2011 closed Pharmacopoeia EudraVigilance Medicinal Product Dictionary (EVMPD). It is fed with product-related information for all medicinal products approved in the countries of the European Economic Area by the respective approval holders. This includes information on the product name, the authorization holder and its pharmacovigilance system, the type and status of the authorization, the pharmaceutical formulation and strength, the type of application and areas of application , as well as the active ingredients and excipients . A detailed, substance-related data record with administrative and technical information should also be created for each active ingredient. The EU drug directory is required in connection with the assignment and processing of the side effect cases reported in the EudraVigilance database and should be ready by July 2, 2012.
  • One directory for investigational drugs is the EudraVigilance Investigational Medicinal Product Dictionary (EVIMPD).
  • The EudraVigilance Data Analysis System (EVDAS) supports the early detection (detection) of drug risks from the data collection.
  • A platform for the publication of the data for the general public.

See also

Web links

Individual evidence

  1. ↑ Access to EudraVigilance data | European Medicines Agency. Retrieved January 17, 2019 .
  2. ^ European database of suspected adverse drug reaction reports. Retrieved January 17, 2019 .