病理用体外诊断试剂国内外分类和监管比较.pdfVIP

Chinese Journal of Medical Instrumentation 2017 年 41 卷第 2 期 监 管 与 测 试 文章编号 1671-7104(2017)02-0127-06 ： 病理用体外诊断试剂国内外分类和监管比较 1, 2 1, 2 1, 3 1, 2 【作 者】石大伟 ，刘东来 ，黄颖 ，张春涛 1 中国食品药品检定研究院，北京市，100050 2 卫生部生物技术产品检定方法及其标准化重点实验室，北京市，100050 3 国家食品药品监督管理总局医疗器械标准管理中心，北京市，100050 【摘 要】该文梳理了我国与美国、欧盟、日本对免疫组织化学和原位杂交体外诊断试剂的分类和监管要求，并对其差异进行了讨 论。研究发现：不同国家(地区)对相关产品的整体分类等级不同，我国和日本偏高；不同国家(地区)的分类等级数量和上 市审批形式不同，集中审批更便于调整。根据研究结果，该文针对该类产品在我国监管给出了一些建议和启示。 【关 键 词】免疫组织化学；原位杂交；分类；分析特异性试剂；实验室自建试剂 F203 【中图分类号】 A doi:10.3969/j.issn.1671-7104.2017.02.014 【文献标志码】 Comparison of Classification and Regulation of in Vitro Diagnostic Products for Clinical Pathology in China and Foreign Country 【Writers 】SHI Dawei1, 2, LIU Donglai1, 2, HUANG Ying1, 3, ZHANG Chuntao1, 2 1 National Institutes for Food and Drug Control, Beijing, 100050 2 Key Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech Products, Beijing, 100050 3 Center for Medical Device Standardization Administration of CFDA, Beijing, 100050 【Abstract 】The classification and the regulatory requirement among U.S., E.U., Japan and China were summarized and compared for the immunohistochemistry and in situ hybridization products. The results indicate that: the regulatory classifications of the related products are higher in Japan and China, than U.S.and E.U.; the classification and regulatory requirement are adjusted more flexibly in the centralized system. The difference was discussed and accordingly some suggestions and implications were given for the China s reg