Improved electronic reporting of suspected adverse reactions for better health protection

27 October 2015

EMA helps stakeholders to plan for enhanced EudraVigilance system

The European Medicines Agency (EMA) has published a EudraVigilance stakeholder change management plan to provide stakeholders with comprehensive information to be ready for improvements to the EudraVigilance system. The plan details the technical changes as well as business process changes in relation to reporting, managing and analysing individual case safety reports (ICSRs) from medicines in clinical use and from clinical trials.

EMA first launched EudraVigilance, a web-based information system of suspected adverse reactions reported with medicines authorised in the European Economic Area (EEA) in December 2001. As a result of updates to the pharmacovigilance and clinical trials legislation, EMA, in collaboration with the rest of the European Union (EU) medicines regulatory network, is now enhancing EudraVigilance in order to deliver better safety monitoring for medicines and a more efficient system for stakeholders.

EudraVigilance is managed by EMA on behalf of the EU medicines regulatory network. It currently registers over one million adverse drug reaction reports per year and is the backbone of the continuous safety monitoring of medicines performed by European regulators.

The enhancements to EudraVigilance specifically aim for:

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

The change management plan includes a timetable of the upcoming changes to EudraVigilance as well as detailed guidance on preparing for the changes. National competent authorities, marketing authorisation holders and sponsors of clinical trials, who will be affected by the changes to Eudravigilance, are advised to consult the change management plan and develop their own internal plans in accordance with their work processes.

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

More about EudraVigilance

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;

Data from EudraVigilance are published in the European database of suspected adverse drug reaction reports.