EMA UPDATE! DAY ZERO FOR MEDICAL LITERATURE REPORTS

The European Medicines Agency (EMA) has issued a new Q&A for marketing authorization holders (MAHs) to clarify timelines regarding identifying individual case safety reports from physical/hard copy local journals.

The European Medicines Agency (EMA) has issued a new Q&A for marketing authorization holders (MAHs) to clarify timelines regarding identifying individual case safety reports from physical/hard copy local journals.
January 30, 2023

Marketing authorisation holders are requested to review and assess reports of suspected adverse reactions from medical literature to identify and record individual case safety reports (ICSRs).

For ICSRs, described in the medical literature containing the minimum criteria, the clock starts (day zero) on the day when the physical/hard copy local journal is received by the organisation/Marketing authorisation holder/Applicant, and this should be considered equal to performing a literature search in an electronic database.

What do I need to know? When an adverse event is reported in physical media, there could be a lag between the paper’s publication and the MAH finding out about the potential issue. In an update to its pharmacovigilance advice, the EMA has clarified that the clock starts on the day the MAH receives the journal.

For further information, you can contact us at: info@asphalion.com

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