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EudraVigilance: Background information (FAQs) What is EudraVigilance? EudraVigilance is a central computer database created by the EMA in December 2001. It contains adverse reaction reports to medicines licensed across the EU. Such reports are received from the EU regulatory agencies and from pharmaceutical companies. What is the purpose of EudraVigilance? To support the public health of EU citizens by collecting safety information on medicines and making this available for scientific assessment. This assessment is carried out by regulatory authorities in the EU that supervise and monitor the correct use of medicines in all EU countries on a continuous basis. Companies that market the medicine can have access to the information relating to their own medicines. In this way they can have a complete picture on what is currently reported in terms of safety and provide prescribers and patients with up-to-date information. Who maintains the EudraVigilance data? EMA staff are dedicated to the upkeep of the database. Information is received from regulatory authorities in the EU and from the companies responsible for particular medicines. This information is then processed and maintained by the EMA. It is made available for continuous safety surveillance. Can health professionals or patients access the data? Not at present but planned for the next few years. This is because the EMA believes that doctors, pharmacists and patients could benefit from receiving feedback based on information in EudraVigilance. This could help improve treatment and prevent side effects. Are SUSARs reported on paper to the EMA and National Competent Authorities? The primary obligation in the Directive 2001/20/EC article 17a is that the sponsor expedites the reports of the SUSARs to the “competent authorities in all the Member States concerned…”. The competent authorities referred to are clearly those in the Member States. EMA is not included in this reference to “competent authorities”. In this context, we can confirm that it is not required that paper SUSAR reports are sent to EMA, irrespective of whether your organisation is already reporting electronically to Eudravigilance or not. If your organisation is in a position to send electronic reports and the competent authorities are in a position to receive them, you can send the SUSARs electronically. Where one or more competent authorities are not in a position to receive electronic reports, then the reports must be sent to them as previously by paper / fax respecting the 7-day and 15-day timeframes. If your organisation is in a position to send SUSARs electronically, these need to be sent to the EudraVigilance Clinical Trial Module, in addition to the paper/electronic reporting to competent authorities in the Member States. If your organisation is not yet in a position to send SUSARs electronically, these need to be sent to the competent authorities in the Member States, as previously, by paper / fax respecting the 7-day and 15-day timeframes. These paper reports should not be sent to EMA. Once your organisation has established electronic reporting capability
then the SUSARs need to be sent electronically to the EudraVigilance
Clinical Trial Module, and to those Member State Competent Authorities
set up to receive the electronic reports. Which are the future plans for EudraVigilance? In the first instance, the best technology available will be employed. In an automated way, it will look at trends in statistics to help EMA and EU regulatory agencies detect safety issues. Once such issues are detected full assessment will be carried out and action taken as appropriate. From 1 May 2004, EudraVigilance receives side effects reported from clinical trials. Other information can be also added in the future to show how medicines are used in practice and how wide the usage per individual medicine is. This will enable EMA to come to more informed decisions on actual impact of adverse reactions in the community. How do I get more information? You can download the following document: Implementation Questions
on transmission of ICSRs to the EVCTM and EVPM
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