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EMA Consults On Using Specific Follow-Up Questionnaires To Improve Safety Reports

 
• By Vibha Sharma

A draft EU guideline outlines the circumstances in which national competent authorities can ask marketing authorization holders to develop specific adverse reaction follow-up questionnaires to ensure the completeness of individual case safety reports.

SideEffects
Completeness of information in Individual Case Safety Reports is essential in many pharmacovigilance assessments • Source: Shutterstock

The European Medicines Agency is inviting feedback on a draft guideline that explains when and how drug sponsors may be asked to prepare specific adverse reaction follow-up questionnaires (Specific AR FUQs) as part of their routine pharmacovigilance activities to gather crucial missing information that may impact the benefit-risk balance of their products or have public health implications. 

Follow-up questionnaires – both general and specific – are commonly used for obtaining key missing information in individual case safety reports (ICSRs) to allow for better characterization of the reported...

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