从非临床研究报告翻译问题引发的对药品申报资料质量的相关思考  

Reflection on the Quality of Drug Application Documents Caused by Translation Issues in Non-Clinical Research Reports

作　　者：李峥 尹茂山 王寅 尹华静 吴爽 于冰 王庆利[1] LI Zheng;YIN Mao-shan;WANG Yin;YIN Hua-jing;WU Shuang;YU Bing;WANG Qing-li(Center for Drug Evaluation,National Medical Products Administration)

机构地区：[1]国家药品监督管理局药品审评中心

出　　处：《中国食品药品监管》2024年第12期46-55,共10页China Food & Drug Administration Magazine

基　　金：2023年河南省研究生教育改革与质量提升工程项目(河南省研究生精品教材项目)药物安全性评价(YJS2023JC05)。

摘　　要：2017年原国家食品药品监督管理总局加入国际人用药品注册技术协调会(ICH),不断推动我国药品注册技术要求与国际接轨,跨国医药企业在我国注册的申报资料与国际通行药品注册申报资料标准也趋于一致,但尚存在非临床研究质量管理规范(GLP)研究报告翻译不规范的问题。翻译不规范问题同样受到境外药品监管机构的关注,2023年美国食品药品监督管理局(FDA)发布了《非临床研究质量管理规范试验报告翻译:问题与解答行业指南(草案)》,对全球化申报过程中非临床研究试验部分申报资料的翻译问题进行了讨论。本文介绍了FDA关于符合GLP要求的研究报告翻译问题的讨论意见,并结合国内药品注册申报过程中非临床申报资料质量问题的实际情况,提出如何进一步提高国内注册申报资料质量,提升国内注册申报水平,为加快药品审评效率提供支撑。In 2017,the former China Food and Drug Administration(CFDA)joined the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use(ICH),continuously promoting the alignment of China's drug registration technical requirements with international standards.While application materials submitted by multinational pharmaceutical companies registered in China are increasingly consistent with globally accepted drug registration standards,issues related to the non-standard translation of Good Laboratory Practice(GLP)research reports persist.These translation challenges have also drawn the attention of international drug regulatory agencies.In 2023,the US Food and Drug Administration(FDA)released the document,"Translation of Good Laboratory Practice Study Reports:Questions and Answers Guidance for Industry(DRAFT GUIDANCE)",which addresses the challenges of translating non-clinical GLP trial application documents in global submissions.This article introduces the FDA's views on the translation of GLP-compliant research reports and,based on the observed quality issues in non-clinical application documents during the domestic drug registration and application process,offers recommendations for improving the quality of domestic registration and application documents.These improvements aim to enhance the level of domestic applications and provide support for accelerating the efficiency of drug reviews.

关 键 词：非临床研究质量管理规范 非临床安全性 申报资料 试验报告 翻译质量 审评效率 

分 类 号：R95[医药卫生—药学]