Guides and Ebooks

Clarifying EMA’s “Day 0” concept for ICSRs.
Reg Intel Update: Impact Assessment – April 2024.

This guide explains the recent changes to the concept of “Day 0” for Individual Case Safety Reports (ICSRs) submitted to the European Medicines Agency (EMA). Day 0 refers to the date the regulatory reporting clock starts for a potential adverse drug reaction.

Key Points:

  • Updated EMA Definition: The March 2024 update defines Day 0 for ICSRs based on when the Marketing Authorization Holder (MAH) identifies enough information to meet the minimum criteria for a valid report.

  • Local Literature: For both hard copy and online/electronic local literature, Day 0 is no longer solely based on the date of receipt. MAHs must promptly review these sources within a week to identify potential ICSRs. Day 0 becomes the date they have sufficient information for a valid report, not exceeding seven days from receipt.
  • Unclear Receipt Date for Online Journals: The guidance remains unclear on when the “receipt date” occurs for online journals. Arriello suggests a conservative approach of considering it the date of awareness, allowing more than seven days for review.

  • Actions for MAHs: The document highlights actions MAHs should take to address the updated guidance, such as reviewing internal processes, training staff, and updating procedures.