欧洲药品管理局（EMA）于2024年5月发布了人参根评估报告及其专论最终版本的修订版，主要包括人参根的物质来源、制剂、化学成分、临床及非临床数据、评估方法、药物警戒等方面进行评估，重点介绍各个部分的总体结论和全文的总体结论以及对具体文献的评估者的评论，该评估报告及其专论与中药对人参药材的传统认识和应用有许多差异。系统介绍EMA该评估报告的核心内容，并深入剖析其与中医药传统认识之间的主要差异，包括理论基础、应用范畴、安全警示及证据标准等方面的异同。通过揭示上述差异，期望引发国内研究者对人参药材现代研究与评价体系的关注，推动传统中药理论与国际草药监管标准的对话与融合，为人参的国际化发展及临床合理应用提供学术参考。

European Medicines Agency (EMA) released the revised final version of the assessment report and the monograph on ginseng root and its preparations in May 2024, which assesses the material origin, preparations, chemical components, clinical and non-clinical data, assessment methods, and post-marketing safety monitoring of ginseng root. It focuses on the overall conclusions of each section and the overall conclusions of the entire report, as well as the comments of the assessors on specific literature. The assessment report and monograph are different from the traditional understanding and application of Chinese medicine for ginseng herbs (Panax ginseng C. A. Mey.).This paper aims to systematically introduce the core content of the EMA assessment report and conduct an in-depth analysis of the primary differences between this report and Traditional Chinese Medicine (TCM) traditional understanding, encompassing disparities in theoretical basis, application scope, safety warnings, and evidence standards. By elucidating these divergences, this paper seeks to draw the attention of domestic researchers to the modern research and evaluation systems for ginseng, promote dialogue and integration between TCM theories and international regulatory standards for herbal medicines, and provide academic references for the international development and rational clinical application of ginseng.

R282.71

中国中医科学院中药研究所“使命导向改革”重点专项（CI2023E001TS01）