Seitz R
Division of Haematology/Transfusion Medicine, Paul-Ehrlich-lnstitut, Langen, Germany.
Dev Biol (Basel). 2007;127:147-52.
New EC legislation ensures a high level of quality and safety of blood and blood components, whatever the intended purpose, throughout the community. Though the initial intention was to strengthen regulatory oversight in the field of blood transfusion services, the Directive 2002/98/EC also has strong implications for the collection and testing of plasma for fractionation. Within the legal framework, as set out by Directive 2002/98/EC, mandatory minimal requirements are laid down by the Commission in further " daughter " Directives, with the assistance of a committee. While allowing some flexibility to the member states to find their specific solutions and regulatory mechanisms in transposition of the Directive, the new legislation advances the approximation of the provisions, thus strengthening the blood supply in the EC. This is an important step towards the ultimate goal to further improve the quality and safety of blood and blood components and to contribute to the confidence of the patients in a safe blood supply in the EC.
欧盟新的法规确保了整个欧盟范围内血液及血液成分无论用于何种目的都具有高水平的质量和安全性。尽管最初目的是加强对输血服务领域的监管，但2002/98/EC号指令对用于分离的血浆的采集和检测也有重大影响。在2002/98/EC号指令所规定的法律框架内，委员会在一个委员会的协助下，在进一步的“子”指令中规定了强制性的最低要求。新法规在允许成员国在转化该指令时有一定灵活性以找到其具体解决方案和监管机制的同时，推进了各项规定的趋同，从而加强了欧盟的血液供应。这是朝着进一步提高血液及血液成分的质量和安全性以及增强患者对欧盟安全血液供应信心这一最终目标迈出的重要一步。
