EMA implements new system for better reporting of suspected adverse reactions to medicines via EudraVigilance

The reporting of suspected adverse reactions to medicines through a pharmacovigilance programme is an important aspect of monitoring their safety, a requirement of clinical trial sponsors and marketing authorisation holders. Suspected adverse reactions are reported through the EudraVigilance database managed by the European Medicines Agency (EMA).

EudraVigilance supports:

  • the electronic exchange of suspected adverse drug reaction reports between EMA, national competent authorities, marketing authorisation holders, and sponsors of clinical trials in the EEA
  • the early detection and continual monitoring and evaluation of possible safety signals associated with medicines for human use
  • regulatory decision making, based on a broader knowledge of the adverse reaction profile of medicines especially in the form of risk management

The EMA has announced plans to improve the EudraVigilance system in terms of both the technical changes and business process changes in relation to reporting, managing and analysing individual case safety reports (ICSRs), the document which provides information on a suspected adverse reaction, from medicines in clinical use and in clinical trials.

The enhancements planned for EudraVigilance follow on from revisions of the European pharmacovigilance and clinical trials legislation, including the Clinical Trials Regulation (536/2014) that is planned to replace Directive 2001/20/EC in 2016. EudraVigilance is being revised to:

  • enhance detection of new or changing safety issues allowing regulatory authorities and pharmaceutical companies to take rapid action to protect public health
  • provide better data analysis tools to support safety monitoring by Member States
  • provide higher quality data and improved search functionality allowing data to be analysed more efficiently
  • ensure compliance with international data standards for individual case safety reports
  • improve performance and scalability to cope with foreseen increase in users of EudraVigilance and volume of data
  • simplify reporting for marketing authorisation holders, who will need to report to EudraVigilance only, with ICSR reports being re-routed to Member States
  • foster collaboration with World Health Organization to exchange information on the monitoring of medicines

To help with the introduction of the changes, EMA has published a change management plan which includes a timetable of the proposed changes and guidance on how clinical trial sponsors and marketing authorisation holders should prepare to use the new system.

EMA has also published an implementation guide with specific EU regional requirements and a set of supporting technical documents on the updated EudraVigilance webpage.

Author: Anthony Lodge

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