欧盟和美国血筛试剂批签发监管制度研究及启示

Research on the Regulation System for the Lot Release of Blood Screening Reagents in EU and USA and the Enlightenment

目的:对我国血筛试剂的批签发检验和监管思路提出建议。方法:研究欧盟和美国对血筛试剂批签发检验和监管的法规及实施现状,结合我国国情及国外监管经验,对我国血筛试剂监管提出建议。结果与结论:为保证血筛试剂质量,欧盟和美国都制定了严格的法律法规,对血筛试剂实施批签发管理。依据《生物制品批签发管理办法》,我国已对血清学检测血筛试剂实施批签发,但核酸检测血筛试剂尚未开展批签发。建议加快推动落实批签发工作,适时增加时限性输血相关传染病标志物的检测试剂批签发项目,指定检验机构开展全部项目检验,以进一步完善我国血筛试剂监管,保障人民用血安全。

Objective:To provide suggestions for testing and regulating the lot release of blood screening reagents in China.Methods:The regulations and implementation status of the lot release of blood screening reagents in European Union(EU)and United States of America(USA)were studied.Suggestions for the regulation of blood screening reagents in China were provided based on our national conditions and the regulation experience abroad.Results and Conclusion:In order to ensure the quality of blood screening reagents,USA and EU have formulated strict laws and regulations to regulate the lot release of blood screening reagents.According to the'Regulations for Lot Release of Biological Products',the lot release has been carried out in blood screening reagents for serological detection in China.However,the lot release of blood screening reagents for nucleic acid testing(NAT)has not yet been carried out.It is necessary to accelerate the implementation of the lot release of NAT,timely increase the lot release projects of the reagents for transfusion-related infectious diseases’markers,and designate particular inspection institutions to conduct tests of all items of blood screening reagents so as to further improve the regulation of blood screening reagents and ensure the safety of blood use in China.