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EMA launches new EudraVigilance system for adverse reactions Posted 30/06/2017

The European Medicines Agency (EMA) announced that it will launch a ‘new and improved version of EudraVigilance’ in November 2017, which will contain enhancements for reporting and analysing suspected adverse reactions.

EudraVigilance is the European Union’s (EU) medicines safety database. It was created in December 2010 as part of pharmacovigilance legislation developed to improve public health by supporting the safety-monitoring of medicines and to increase the transparency of EMA [1]. 

EMA expects the new EudraVigilance system to ‘support better safety monitoring of medicines and a more efficient reporting process for stakeholders’. Expected benefits include:

  • Simplified reporting of individual case safety reports (ICSRs)
  • Better detection of new or changing safety issues, enabling rapid action to protect public health
  • Increased transparency based on broader access to reports of suspected adverse reactions by healthcare professionals and the general public via the adrreports.eu database
  • Enhanced search and more efficient data analysis capabilities
  • Increased system capacity and performance to support large volumes of users and reports (including non-serious adverse reactions originating from the EEA [European Economic Area])
  • More efficient collaboration with the World Health Organization (WHO) – EMA will make individual cases of suspected adverse reactions directly available to WHO; Member States will no longer need to carry out this task

The new version of EudraVigilance will go live on 22 November 2017 with enhanced functionalities for reporting and analysing suspected adverse reactions. The agency warned that, before this date, users of the system, i.e. national competent authorities, marketing authorization holders and sponsors of clinical trials, ‘have to make final preparations to ensure that their processes and local IT infrastructure are compatible with the new system and the internationally agreed format’.

There will be no changes to the reporting of adverse reactions by patients and healthcare professionals. There will also be no changes to reporting of suspected unexpected serious adverse reactions during clinical trials until the application of the new Clinical Trial Regulation.

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1. GaBI Online - Generics and Biosimilars Initiative. Pharmacovigilance legislation moves a step closer [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jun 30]. Available from: www.gabionline.net/Policies-Legislation/Pharmacovigilance-legislation-moves-a-step-closer

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Source: EMA

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