目前，中药注射剂上市后临床安全性评价研究水平参差不齐，过程质量难以保证，因此亟需相关技术指导。本课题组通过借鉴国际药品上市后安全性评价的经验和方法，结合中药注射剂的特点，从研究准备、实施及总结3个阶段，提出中药注射剂上市后临床安全性评价过程质量控制技术规范，具体包括科学性、伦理、透明、数据管理、统计分析、规范报告等方面，全面介绍保证研究质量有必要采取的技术和方法，为中药注射剂上市后临床安全性评价研究提供借鉴。

At present,the various levels of safety evaluations of traditional Chinese medical(TCM)injections were in force in post-marketing clinical researches,while the process quality is guaranteed with difficulty.Therefore,it is requisite to call for technical guidance.By drawing lessons from the international experience of drug marketing safety evaluation and the related methods,we proposed the key techniques of quality control for clinical safety evaluation of TCM injections from the three aspects:preparation,implementation and summarization of researches,combining with the characteristics of TCM injections.The key techniques contained some scientific problems,ethics,publicity,data management,statistical analysis,specification report,etc.This paper comprehensively introduced the requisite technologies and methods over research quality,laying a foundation for the studies of post-marketing clinical safety evaluation of TCM injections.

科学技术部“十二五”重大新药创制“科技重大专项”课题（2011ZX09304-08）：大品种药物Ⅳ期临床试验及新药临床试验审评研究技术平台，负责人：杜晓曦；天津市卫生和计划生育委员会中医中西医结合科研课题（2015073）：中药注射剂致变态反应特征与危险因素的文献分析，负责人：郑文科。