EMA publishes Reflection Paper on Viral Safety of plasma-derived Medicinal Products with Respect to Hepatitis E Virus

Recommendation

7/8 May 2024

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

As announced in "Hepatitis E Virus - Reflection Paper on Viral Safety" in August 2015, the European Medicines Agency (EMA) published  the Reflection paper on viral safety of plasma-derived medicinal products with respect to Hepatitis E virus for consultation until end of September 2015. In this time nearly 40 comments were submitted, from individual persons as well as from organisations like the European Society for Paediatric Gastroenterology Hepatology and Nutrition (ESPGHAN) - Hepatology Committee or  the International Plasma Fractionation Association (IPFA). Some of them were accepted and the changes and reference updates added to the document.

After the changes were agreed to by the Biologics Working Party and by the Blood Products Working Party, the CHMP adopted the Reflection paper on 23 June. The adopted document now includes the following contents:

1. Introduction
2. Discussion
2.1. Transfusion-associated infections and clinical experience with HEV-infections
2.2. HEV detection and epidemiology of HEV in blood/plasma donations
2.3. Do serum antibodies against HEV significantly neutralise?
2.4. Studies on inactivation/removal of HEV during manufacture of plasma-derived medicinal products
2.5. Risk assessment for plasma-derived medicinal products
3. Conclusion
4. References
Appendix: summaries of individual presentations from the EMA Workshop on Viral safety of plasma-derived medicinal products with respect to hepatitis E virus, 28-29 October 2014

For more details, please read the "Reflection paper on viral safety of plasma-derived medicinal products with respect to Hepatitis E virus".