Center for Drug Reevaluation, SFDA, Beijing 100045, China.
J Ethnopharmacol. 2012 Apr 10;140(3):519-25. doi: 10.1016/j.jep.2012.01.058. Epub 2012 Feb 21.
Traditional Chinese Medicine (TCM), including Traditional Chinese Medicine drugs (TCM drugs), has been playing a very important role in health protection and disease control for thousands of years in China. Relying on natural products, mainly of herbal origin, used either as raw materials for decoction, as prepared herbal medicines or as formulated traditional medicines, TCM is still widely accepted by Chinese people, especially for chronic diseases treatment. This extensive use warrants safety measures and so TCM drug safety monitoring and risk management are becoming increasingly important tasks for the Chinese State Food and Drug Administration (SFDA).
The Adverse Drug Reaction (ADR) monitoring system in China was established both for western and TCM drugs in 1989 as a voluntary reporting system with a National Center collecting and compiling reports. Serious or multi-case reports on individual TCM drug or formulated products are detailed in the Chinese ADR Information Bulletin to inform the public and Drug Administrative authorities for risk management.
About 10-15% of the ADR reports received by the National Center are related to TCM drugs and mainly pertaining to the formulated products. In certain cases, the suspension of a particular TCM preparation is decided by SFDA China.
The model of safety monitoring and risk management of TCM drugs is still under exploration. Indeed, the characteristics and risk factors associated with these drugs require both proper understanding and control of the risk by strengthening standardization of clinical applications, basic science research, quality control in manufacturing, exploration of the actives monitoring methodology and enhancement of international communication and cooperation.
中药（TCM），包括中药药物（TCM 药物），在中国几千年的健康保护和疾病控制中发挥了非常重要的作用。TCM 依赖于天然产品，主要来源于草药，用作汤剂的原料、制备的草药或配方的传统药物，仍然被中国人广泛接受，特别是用于治疗慢性病。这种广泛的使用需要安全措施，因此 TCM 药物安全性监测和风险管理成为中国国家食品药品监督管理局（SFDA）日益重要的任务。
中国的不良反应（ADR）监测系统于 1989 年同时为西药和中药建立，作为一个自愿报告系统，国家中心收集和编译报告。个别 TCM 药物或配方产品的严重或多例报告详细列在《中国 ADR 信息通报》中，以告知公众和药物管理当局进行风险管理。
国家中心收到的 ADR 报告中约有 10-15%与 TCM 药物有关，主要与配方产品有关。在某些情况下，SFDA 中国决定暂停某种 TCM 制剂的使用。
TCM 药物的安全性监测和风险管理模式仍在探索中。事实上，这些药物的特点和风险因素需要通过加强临床应用的标准化、基础科学研究、制造过程中的质量控制、探索主动监测方法以及增强国际交流与合作来正确理解和控制风险。
