Viral safety of plasma-derived medicinal products with respect to hepatitis E virus - Scientific guideline

This document addresses the viral safety of plasma-derived medicinal products with respect to hepatitis E virus. It discusses HEV reduction by specific manufacturing steps and risk assessment for these products.

Keywords: Hepatitis E virus, plasma-derived products, blood infectivity

Current effective version

Reflection paper on viral safety of plasma-derived medicinal products with respect to Hepatitis E virus

Adopted Reference Number: EMA/CHMP/BWP/723009/2014 Summary:

Hepatitis E virus (HEV) is a causative agent of hepatitis in many countries and of emerging concern in industrialised countries. HEV is a non-enveloped, single-stranded, positive-sense RNA virus and a member of the family Hepeviridae. In developing countries, HEV (genotypes 1 and 2) is a major cause of acute hepatitis, transmitted by the faecal–oral route and associated with contamination of drinking water.

Document history

Overview of comments received on 'Reflection paper on viral safety of plasma-derived medicinal products with respect to Hepatitis E virus’

Reference Number: EMA/CHMP/BWP/744742/2015

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

Draft: consultation closed Consultation dates: 01/07/2015 to 30/09/2015 Reference Number: EMA/CHMP/BWP/723009/2014 Summary:

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.

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

Draft: consultation closed Consultation dates: 02/05/2014 to 31/07/2014 Reference Number: EMA/CHMP/BWP/78086/2014 Summary:

Viral safety of plasma-derived medicinal products needs to be kept under review as viruses are identified that can be present in the plasma starting material. Initiating action with a workshop will provide an effective means of bringing together and discussing the currently available information on this topic. This will then allow further actions to be identified.