Pharma Disappointed By New Extension Of EU Signal Detection Pilot
EFPIA Says Further Extension Was Not Expected
A further extension of the EU signal detection pilot means that certain drug sponsors must keep monitoring the EudraVigilance database on a continuous basis. Industry argues there is enough evidence that this activity brings no additional value, and that current requirements should be replaced with a more proportionate approach.
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The European Commission is consulting on a range of proposals to overhaul a nine-year-old regulation on drug safety reporting procedures.
The pilot phase of a European project on new safety signal notification requirements has been extended for a second time following inconclusive results.
Drug companies say that any decision on taking the EudraVigilance monitoring requirements into the next phase should only be made when there is clear evidence that it has improved patient safety.