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

More from Europe

More from Geography