Epstein Jay, Seitz Rainer, Dhingra Neelam, Ganz Peter R, Gharehbaghian Ahmad, Spindel Renato, Teo Diana, Reddy Ravi
Food and Drug Administration, Rockville, MD, USA.
Biologicals. 2009 Apr;37(2):94-102. doi: 10.1016/j.biologicals.2009.01.004. Epub 2009 Feb 20.
In this paper the authors discuss the role of regulation in assuring blood safety. After an overview of the subject by a leading expert, examples are provided of regulatory systems for blood transfusion services in several countries and regions. Additionally, the perspective of WHO is given on the essential role of national regulatory authorities in assuring the quality of national blood programmes. Collectively, the sections of this paper afford an opportunity for readers to make comparisons among different regulatory frameworks and to "benchmark" among the existing systems. Despite many differences in approach, a clear pattern emerges of worldwide efforts to strengthen blood regulatory systems.
在本文中，作者们讨论了监管在确保血液安全方面的作用。在一位顶尖专家对该主题进行概述之后，列举了几个国家和地区输血服务监管系统的实例。此外，还介绍了世界卫生组织对于国家监管机构在确保国家血液项目质量方面的关键作用的观点。总体而言，本文各章节为读者提供了一个机会，以便在不同的监管框架之间进行比较，并在现有系统中进行“对标”。尽管在方法上存在许多差异，但全球加强血液监管系统的努力呈现出一种清晰的模式。
