中文摘要：

血液制品是以健康人血浆为原料生产制备的一种特殊＂药品＂,自20世纪80年代经血液制品传播人类免疫缺陷病毒事件频发以来,如何确保血液制品病毒安全性倍受关注。经过数十年的努力,目前各国均形成了严密体系,通过多种预防控制措施确保血液制品的病毒安全性,包括原料血浆的控制、生产过程中的病毒灭活/去除处理、严格遵守药品生产质量管理规范等。未来,新发传染病病原体将对血液制品的病毒安全性造成新的威胁,因此需不断研究新的应对措施。

英文摘要：

Plasma products are considered to be special ＂medicines＂ derived from healthy human plasma. During 1980＇s, events of transmission of human immunodeficiency virus through plasma products were frequently reported. Since then, ensuring the viral safety of plasma products has raised great concerns all over the world. So far, with decades of effort, most countries in the world have established rigorous systems with preventive measures to ensure the viral safety of plasma products. These measures include control of source plasma, validated inactivation/removal of infectious agents, the adherence to current good manufacturing practices. Nevertheless, new infectious agents which may be threats to viral safety require continuous studies on appropriate