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EU Safety Signal Detection Pilot Extended Again

Few Signals And A Lot Of Work

 
• By Ian Schofield

The pilot phase of a European project on new safety signal notification requirements has been extended for a second time following inconclusive results. 

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EU drug safety monitoring project is linked to EudraVigilance

The European Medicines Agency says the pilot EU project on drug safety signal detection is being extended again because “more robust data” are needed before the project is rolled out to all manufacturing authorization holders. A relatively low number of signals have been notified under the pilot to date, and only one of these was considered worthy of evaluation.

Manufacturers of the 300-odd substances involved have been told to carry on monitoring them for the duration of the pilot,...

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