中药注射剂上市后临床安全性评价研究的过程质量控制技术规范(征求意见稿)

The Process Quality Control and Key Technology of Post-Marketing Clinical Safety Evaluation of Chinese Medical Injection (Draft Report for Comment)

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.