EMA: Draft reflection paper on viral safety of plasma-derived medicinal products with respect to hepatitis E virus

Hepatitis E virus (HEV) infection is widespread and blood/plasma donors are often asymptomatic. Therefore, there is a risk for viraemic blood donations. This raises questions about the safety of plasma-derived medicinal products. This reflection paper considers transfusion-associated infections and clinical experience with HEV-infections, HEV detection and epidemiology of HEV in blood/plasma donations, if serum antibodies against HEV significantly neutralise, studies on inactivation/removal of HEV during manufacture of plasma-derived products, and risk assessment for plasma-derived medical products.

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