Yesterday, 22nd November 2017, The European Medicines Agency (EMA) launched yesterday, a new and improved EudraVigilance system. EudraVigilance is the European information system of suspected adverse reactions to medicines that are authorised or being studied in clinical trials in the European Economic Area (EEA). During this period, the electronic reporting of individual case safety reports (ICSRs) by NCAs, MAHs and sponsors will be disrupted, while the electronic submission of data on medicines (Article 57) will be unavailable.
The new system has enhanced features for the reporting and analysis of suspected adverse reactions to support a better safety monitoring of medicines and a more efficient reporting process for stakeholders. Expected benefits:
- Simplified reporting of ICSRs and re-routing of ICSRs to Member States, as MAHs will no longer have to provide these reports to NCAs, but directly to EudraVigilance;
- Better detection of new or changing safety issues;
- Increased transparency based on broader access to reports of suspected adverse reactions via the adrreports.eu portal.
- Enhanced search and more efficient data analysis capabilities;
- Increased system capacity and performance to support large volumes of users and reports;
- More efficient collaboration with the World Health Organisation, as EMA will make the reports of individual cases of suspected adverse reactions within EEA available to WHO Uppsala Monitoring Centre Directly from Eudravigilance (Member States will not have to do this task anymore).
After the go-live of the new system, the old EudraVigilance continues working, however, it is restricted to functionalities related to extended EudraVigilance Medicinal Products Dictionary (xEVMPD) and the electronic data submission on medicines (Article 57).
The following important documents are now published on the Eudravigilance website, supporting of using the new sytem:
- EVWEB release notes – new
- EVWEB User Manual (updated)
- EVDAS release notes for MAHs – new (published on the EVDAS welcome page)
- EVDAS user manual for MAHs – new
- XCOMP release notes (updated)
For the latest information, please visit the new EMA dedicated webpages:
- EudraVigilance
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