EMA has released a detailed guidance on ICSRs in the context of COVID-19

ICSRs in COVID-19

EMA has released a detailed guidance on ICSRs in the context of COVID-19

On April 21, EMA has released a document providing recommendations to the processing and submission of Individual Case Safety Reports (ICSRs) associated with medicinal products used for the treatment or prevention of COVID-19 infection, taking into account the Notice to stakeholders – Questions and answers on regulatory expectations for medicinal products for human use during the covid-19 pandemic published by the European Commission and the guidance regarding COVID-19 related terms published by the MedDRA MSSO.

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