摘要
通过对中药复方和欧盟草药复方临床前安全性评价要求的介绍、分析,比较中欧双方在临床前安全性评价资料提交以及内容方法上的差异,为中药复方更好地适应欧盟草药复方临床前安全性评价的法律性规范起到指引的作用。
The requirements for pre-clinical safety evaluation of compound traditional Chinese medicine and the European Union compound herbs were introduced and analyzed in this paper. The difference of both sides in data submission, content and method of pre-clinical safety evaluations was compared so as to provide instructions for the compound traditional Chinese medicine to follow the legal practice in pre-clinical safety evaluation as done by European Union compound herbs
出处
《中国执业药师》
CAS
2011年第11期30-32,39,共4页
China Licensed Pharmacist
关键词
中药复方
欧盟草药复方
临床前安全性评价
Compound Traditional Chinese Medicine
European Union Compound Herbs
Pre-clinical Safety Evaluation
