Institute of Pharmaceutical Sciences, TCM Research Center, Graz, Austria.
Planta Med. 2010 Dec;76(17):2004-11. doi: 10.1055/s-0030-1250532. Epub 2010 Nov 12.
The actual concern about the safety and efficacy of herbal drugs originating from traditional Chinese medicine (TCM) is based on observations that these medicinal plants may have a high risk potential due to insufficient definitions, problems with identity, purity and falsifications. No uniform legal status for these groups of herbal drugs currently exists in the European Union. For quality control, monographs for TCM herbs can mainly be found in the Pharmacopoeia of the Peoples Republic of China. Based on these facts the Commission of the European Pharmacopoeia decided in 2005 to establish TCM-herbal drug monographs for the most important medicinal plants imported from Far East. These new monographs had to be established and evaluated on the basis of existing monographs in the Chinese Pharmacopoeia (ChP), English edition 2005. Due to important differences in the overall features of EP and ChP, a simple adapt/adopt procedure was not feasible. Therefore, specialist groups were mandated with a corresponding working programme. Some results and actual problems related to this working programme will be presented and discussed.
人们实际上关注源于中医药的草药药物的安全性和疗效，是基于这些药用植物可能因定义不充分、身份、纯度和伪造问题而具有高风险潜力的观察结果。在欧盟，这些草药药物群体目前没有统一的法律地位。对于质量控制，中医药草药的专论主要可以在《中华人民共和国药典》中找到。基于这些事实，欧洲药典委员会于 2005 年决定为从远东进口的最重要药用植物建立中医药草药专论。这些新的专论必须基于中国药典（ChP），2005 年英文版中的现有专论来建立和评估。由于 EP 和 ChP 在总体特征方面存在重要差异，因此简单的适应/采用程序不可行。因此，专家组被授权执行相应的工作计划。将介绍和讨论与该工作计划相关的一些结果和实际问题。
