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End In Sight For Onerous EU Signal Detection Pilot

 
• By Vibha Sharma

A keenly-awaited legislative amendment that is expected to be adopted by the end of this year would introduce more proportionate requirements for drug sponsors to monitor the EudraVigilance database.

Stethoscope placed on top of the sheet with statistical graphs
Companies rely on a broad range of data sources to monitor the safety their drugs • Source: Shutterstock

An EU pilot program on monitoring drug safety may be soon be terminated, after running for over six years and generating, according to the industry, little additional value in terms of improving patient safety.

The European Commission is working on a legislative amendment that is expected to put an end to the EU signal detection pilot, under which sponsors of certain medicines (ie, those...

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