European Union:
New Eudravigilance Database Launched
28 November 2017
Arnold & Porter
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A quick note to inform you that the EMA launched its new
improved version of the Eudravigilance
system on 22 November 2017. It is now mandatory to report suspected
ADRs through the new system.
The new system has been designed to offer "enhanced
features for the reporting and analysis of suspected adverse
reactions, to support stronger safety monitoring of medicines and a
more efficient reporting process for stakeholders". It
will be interesting to monitor whether the system delivers these
improvements, as time passes, and users become more familiar with
it.
For further information, please refer to our previous
blog and the attached guidance.
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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