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As of 20 November 2005, electronic reporting is mandatory across the European Economic Area (EEA). This is in accordance with Regulation (EU) No. 726/2004 and Directive 2001/83/EC as amended. Furthermore, for Suspected Unexpected Serious Adverse Reactions (SUSARs) occurring during clinical trials, electronic reporting requirements are defined in the implementing texts of Directive 2001/20/EC. The exchange of Individual Case Safety Reports (ICSRs) based on the standards agreed at the level of the International Conference on Harmonization (ICH) has been widely implemented and paperless submissions to the EMEA and many EU national Competent Authorities is now a reality.

The electronic transmission of ICSRs is a key element in improving the process of adverse reaction reporting in pharmacovigilance. It is not only a major step forward in providing information more rapidly but also in standardizing the way clinical safety data elements are presented, thereby improving the collective ability to evaluate complex data.