上市后中成药临床安全性再评价的现状、问题与展望

Present status, problems and outlook of safety evaluation for the proprietary Chinese medicine

关键词:  临床评价  安全性  中成药  上市后

Key words:  clinical assessment  safety  Chinese patent medicine  post-marketing

摘要:

文章对目前我国中成药临床安全性评价现状进行了客观阐述。中成药安全性问题已经引起社会的广泛关注，既往的中成药临床安全性评价存在各种局限性，缺乏科学证据，因此，上市后中成药临床安全性评价工作刻不容缓。目前，国家监管部门、科研院所、医药企业等各方面正积极探索，开展相关工作，取得了可喜成绩。但其中仍存在诸如相关规范、顶层设计、质量控制、利益相关性等各方面的问题，需要进一步完善中成药安全性评价体系。

Abstract:

The article objectively discusses the present status of safety evaluation for the proprietary Chinese medicine in China. Traditional Chinese medicines' security issues have been caused extensive concern by society, there are many limitations of proprietary Chinese medicine in safety evaluation, for lack of scientific evidence, the post-marketing safety evaluation work of TCM is urgently needed. At present, the goverment, institutes, pharmaceutical companies of TCM and so on are actively exploring and carrying out related works, and have made gratifying achievements. But there still exist various aspects of related questions, such as the relevant specification, the top-level design, quality control, benefit and so on. There are some more work for further improving the safety evaluation system of proprietary Chinese medicine.