The ICH E2B(R2) standard used for expedited reporting of adverse event reports became mandatory in EU since November 2005. In an attempt to make the standard and the electronic case reporting more useful and compliant with current pharmacovigilance practices, a new version referred to as ICH E2B(R3), has been on the way for some years.

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In order to harmonise the performance of the new pharmacovigilance activities introduced by the amended pharmacovigilance legislation, the European Commission shall adopt several implementing measures. This public consultation offers the opportunity for stakeholders to submit feedback. Read more about public consultation on a concept paper on implementing measures for the performance of pharmacovigilance [...]