我国临床实验室自建检测方法管理优化及对策建议
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摘要
目的为我国进一步完善实验室自建检测方法(LDT)的监管提供参考。方法梳理当前我国关于LDT的政策,借鉴欧美等发达国家对于LDT管理的经验及制度,结合我国发展现状及面临的问题提出对策与建议。结果与结论我国对LDT的监管缺失,亟须明确国内LDT的定义和范围,对纳入LDT范畴进行监管的实验室实行准入管理,制订并实施相应的质量管理规范。
Objective To provide reference for improving regulation of laboratory developed tests( LDT) in China. Methods The current policy of LDT in China was reviewed,and the countermeasures and suggestions were put forward based on the experience and system of LDT management in developed countries such as Europe and America and the current situation and problems in China. Results and Conclusion Lack of regulation on LDT in China urgently needs to clarify the definition and scope of LDT in China,conduct access administration on laboratories in the scope of LDT,and formulate corresponding quality management standards.
Objective To provide reference for improving regulation of laboratory developed tests( LDT) in China. Methods The current policy of LDT in China was reviewed,and the countermeasures and suggestions were put forward based on the experience and system of LDT management in developed countries such as Europe and America and the current situation and problems in China. Results and Conclusion Lack of regulation on LDT in China urgently needs to clarify the definition and scope of LDT in China,conduct access administration on laboratories in the scope of LDT,and formulate corresponding quality management standards.
引文
[1]中华医学会检验医学分会.我国医学检验部门自建检测方法发展与管理建议[J].中华检验医学杂志,2017,40(3):162-164.
[2]THOMPSON BM,SCOTT BI,BOIANI JA.Understanding the Food and Drug Administration's Jurisdiction Over Laboratory-Developed Tests and Divisions Between Food,Drug,and Cosmetic ActRegulated and Clinical Laboratory Improvement Amendments of1988-Regulated Activities[J].Clinics in Laboratory Medicine,2016,36(3):575-585.
[3]刘东来,石大伟,张春涛.美国对实验室研发诊断试剂的监管之路[J].中国新药杂志,2016,25(3):244-252.
[4]WEISS RL.The long and winding regulatory road for laboratorydeveloped tests[J].Am J Clin Pathol,2012,138(1):20-26.
[5]O'LEARY TJ.Regulating laboratory-developed tests[J].J Mol Diagn,2014,16(6):595-598.
[6]42U.S.C.263a PL100-578,Senate and House of Representatives of the United States of America in Congress:Clinical Laboratory Improvement Amendments of 1988[S].
[7]刘维薇,郑特,徐科,等.国外实验室自建项目管理带给我们的启示[J].中华临床实验室管理电子杂志,2014,2(3):1-4.
[8]U.S.Department of Health and Human Services,US Food and Drug Administration,Center for Devices and Radiological Health,et al.Draft guidance for industry,food and drug administration staff,and clinical laboratories:framework for regulatory oversight of laboratory developed tests(LDT).[EB/OL].(2014-10-03)[2019-02-05].http://www.fda.gov/downloads/MedicalDevices/Device RegulationdGuidance/GuidanceDocuments/UCM416685.pdf.
[9]王蓓丽,郭玮,潘柏申.国外医学检验实验室自建检测方法监管现状[J].中华检验医学杂志,2016,39(1):55-59.
[10]RAY T.FDA Holding Off on Finalizing Regulatory Guidance for Lab-Developed Tests[EB/OL].(2016-11-08)[2019-02-05].https://www.genomeweb.com/molecular-diagnostics/fda-holding-finalizing-regulatory-guidance-lab-de veloped-tests.
[11]秦辉.欧盟体外诊断医疗器械指令(IVDD)及CE认证[J].中国医疗器械杂志,2008,32(2):153.
[12]TAZAWA Y.Perspective for the development of companion diagnostics and regulatory landscape to encourage personalized medicine in Japan[J].Breast Cancer,2016,23(1):19-23.
[2]THOMPSON BM,SCOTT BI,BOIANI JA.Understanding the Food and Drug Administration's Jurisdiction Over Laboratory-Developed Tests and Divisions Between Food,Drug,and Cosmetic ActRegulated and Clinical Laboratory Improvement Amendments of1988-Regulated Activities[J].Clinics in Laboratory Medicine,2016,36(3):575-585.
[3]刘东来,石大伟,张春涛.美国对实验室研发诊断试剂的监管之路[J].中国新药杂志,2016,25(3):244-252.
[4]WEISS RL.The long and winding regulatory road for laboratorydeveloped tests[J].Am J Clin Pathol,2012,138(1):20-26.
[5]O'LEARY TJ.Regulating laboratory-developed tests[J].J Mol Diagn,2014,16(6):595-598.
[6]42U.S.C.263a PL100-578,Senate and House of Representatives of the United States of America in Congress:Clinical Laboratory Improvement Amendments of 1988[S].
[7]刘维薇,郑特,徐科,等.国外实验室自建项目管理带给我们的启示[J].中华临床实验室管理电子杂志,2014,2(3):1-4.
[8]U.S.Department of Health and Human Services,US Food and Drug Administration,Center for Devices and Radiological Health,et al.Draft guidance for industry,food and drug administration staff,and clinical laboratories:framework for regulatory oversight of laboratory developed tests(LDT).[EB/OL].(2014-10-03)[2019-02-05].http://www.fda.gov/downloads/MedicalDevices/Device RegulationdGuidance/GuidanceDocuments/UCM416685.pdf.
[9]王蓓丽,郭玮,潘柏申.国外医学检验实验室自建检测方法监管现状[J].中华检验医学杂志,2016,39(1):55-59.
[10]RAY T.FDA Holding Off on Finalizing Regulatory Guidance for Lab-Developed Tests[EB/OL].(2016-11-08)[2019-02-05].https://www.genomeweb.com/molecular-diagnostics/fda-holding-finalizing-regulatory-guidance-lab-de veloped-tests.
[11]秦辉.欧盟体外诊断医疗器械指令(IVDD)及CE认证[J].中国医疗器械杂志,2008,32(2):153.
[12]TAZAWA Y.Perspective for the development of companion diagnostics and regulatory landscape to encourage personalized medicine in Japan[J].Breast Cancer,2016,23(1):19-23.