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EU Extends Pilot Of New Drug Safety Reporting System

 
• By Ian Schofield

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.

SideEffects
The drug safety system pilot is to be extended in the EU. • Source: Shutterstock

The European Medicines Agency says that the one-year pilot of the revamped EudraVigilance safety reporting system, which was due to end next month, is to be extended indefinitely so that regulators and pharmaceutical companies can gain more experience with the system.

EudraVigilance was enhanced in November 2017 to make reporting easier for marketing authorization holders and to allow better analysis of...

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