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.
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.
