EU Allows Pharma To Temporarily Prioritize Reporting For COVID-19 Adverse Events
Prioritization Allowed Until The Pandemic Is Resolved
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.
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Early disruptions caused by the coronavirus pandemic prompted the European pharmaceutical industry body, EFPIA, to establish a principles-based framework to help ensure consistency in managing compliance with pharmacovigilance responsibilities.
Guidance is now available to help drug companies that use the EU mutual recognition and decentralized procedures to handle regulatory processes during the COVID-19 crisis.
Regulatory authorities have adapted the EU medicines framework to help pharmaceutical companies cope with the consequences of the COVID-19 pandemic.