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EU Allows Pharma To Temporarily Prioritize Reporting For COVID-19 Adverse Events

Prioritization Allowed Until The Pandemic Is Resolved

 
• By Vibha Sharma

Drug companies unable to continue with standard reporting of suspected adverse reactions to the EU pharmacovigilance database can temporarily prioritize their reporting activities to focus on COVID-19 related safety events.

SideEffects
EU Has Extended COVID-19 Regulatory Flexibilities To Safety Reporting • Source: Shutterstock

Drug companies are being temporarily allowed to readjust their adverse event reporting priorities in the EU to give the highest precedence to serious incidents associated with medicinal products used for treating or preventing COVID-19.

This temporary mechanism of prioritizing which suspected adverse reactions or individual case safety reports (ICSRs) should be first reported to the EU pharmacovigilance database will be available for companies that are unable to continue with

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