EMA launches new EudraVigilance system for adverse reactions

Home/Policies & Legislation | Posted 30/06/2017 post-comment0 Post your comment

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.

147 AA010665

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.

Related article
EMA publishes guidance on publication of clinical trials data

Reference
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

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2017 Pro Pharma Communications International. All Rights Reserved.

Source: EMA

comment icon Comments (0)
Post your comment
Related content
FDA publishes final Q&A on biosimilar development and the BPCI Act
Question-Fimea-V15E29
Home/Policies & Legislation Posted 15/10/2021
FDA voices concerns around drug patents and competition
Patent 1 V13E17
Home/Policies & Legislation Posted 08/10/2021
USA BIOSIM Act introduction
02 AA010638
Home/Policies & Legislation Posted 17/09/2021
Most viewed articles
About GaBI
Home/About GaBI Posted 05/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010