Enhanced EudraVigilance System Goes Live, EMA Updates Info For Users
After months of preparations, the European Medicines Agency’s improved pharmacovigilance database has gone live on schedule.
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Testing of the enhanced EU drug safety reporting system, EudraVigilance, is to be extended beyond February in an effort to gain more information on how stakeholders are finding the new requirements.
The European Commission has agreed to extend the ongoing signal detection pilot involving the revamped EU pharmacovigilance database and has asked for a report on experience in the first year.
The pilot was launched to support a phased implementation of new EU requirements relating to monitoring and reporting drug safety information.