On June 25, 2015, EMA published a draft reflection paper on viral safety of plasma-derived medicinal products with respect to hepatitis E virus. The draft document analyzes the transfusion-associated infections and clinical experience with HEV-infections, HEV detection and epidemiology of HEV in blood/plasma donations, serum antibodies against HEV, inactivation/removal of HEV during manufacture of plasma-derived products, and risk assessments for plasma-derived medical products. Comments are due August 30, 2015.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.