FDAnews Drug Daily Bulletin

EMA Publishes Checklist Ahead of November EudraVigilance Update

June 29, 2017

The European Medicines Agency published a step-by-step guide for drugmakers to prepare for the implementation of the new EudraVigilance adverse event monitoring system, scheduled for Nov. 22.

The EMA’s technical checklist includes timelines for the upcoming months, including deadlines for updating local pharmacovigilance systems used in sending individual case safety reports, to ensure proper transmission to the database.

Before November, sponsors should test their systems to make sure they can receive Individual Case Safety Reports in the ICH E2B(R3) format. The EMA has provided test files with scenarios including fatalities, clinical trial reports, follow-ups, parent-child reports and reports involving advanced or combination therapies that may have a device component.

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