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

Recommendation

9/10 May 2023
Heidelberg, Germany

Annex 2 & Co. - GMP Compliance for Biopharmaceuticals
Regulatory Requirements and Practical Implementation

Related to the fact, that HEV infection is widespread and blood/plasma donors are often asymptomatic, there is a risk for viraemic blood donations. Transfusion related cases of HEV infection has been documented in several countries, e.g. in United Kingdom, France, Japan, Saudi Arabia and People’s Republic of China. The recent analysis of donations of blood and plasma has identified HEV-infected donors in Germany, Sweden, and United Kingdom. In these studies, the frequency of viraemic donations ranged between 1:4000 and 1:7000.

Thus the EMA recognised that further information is needed on the safety of plasma-derived medicinal products with respect to HEV.

Therefore, an expert workshop will be organised in 2014 to address the relevant issues. The following points should be addressed:

• Transfusion-associated infections and clinical experience with HEV-infections.
• Latest information on the epidemiology of HEV infection with focus on blood and plasma donors.
• Duration of viraemia and virus loads of blood and plasma donations.
• Potential testing methods for screening of donors and testing of plasma pools (NAT, reference materials).
• HEV-specific antibodies and neutralisation.
• Latest information about the development of cell culture systems for HEV and their feasibility for 55 validation of virus inactivation/removal.
• Latest experience from studies on inactivation/removal of HEV.
• Relevance of model viruses for evaluation of virus inactivation/removal of HEV.
• Safety of solvent-detergent treated plasma.
• Risk assessment for plasma-derived medical products and implication for warning statements.
• Perspective from patients.

This workshop will provide the basis for deciding what further action may be needed, including the  possible update of current guidance on plasma-derived medicinal products and/or development of a  reflection paper specifically on viral safety of plasma-derived medicinal products with respect to  hepatitis E virus.

Please see the complete document entitled "Concept paper on viral safety of plasma-derived medicinal products with respect to hepatitis E virus".