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.

Concept of health care, medicine, pharmacy, COVID-19, coronavirus. Assortment of pharmaceutical products, white and pink pills with a magnifying glass
Evaluation of safety signals is part of routine pharmacovigilance activity for drug companies • Source: Alamy

An EU pilot under which sponsors of medicines subject to additional monitoring are required by law to continuously check the EudraVigilance database and report validated safety signals about their products to regulators has been extended yet again – this time until the end of 2023.

The further extension of the signal detection pilot comes as a disappointing surprise for companies, which say the mandatory continuous...

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