应进一步加强复方丹参滴丸临床实验研究

Enhancing clinical trials of Compound Danshen Dripping Pill

根据《天士力医药集团股份有限公司关于复方丹参滴丸美国FDA新药申报可行性会议情况的公告》,我们对复方丹参滴丸临床试验未能通过美国FDA审评,新药注册受阻,Ⅱ、Ⅲ期临床试验结果不同,药厂公告真实性,申报剂型及制剂不同等问题进行探讨,并提出建议。

Based on TASLY’ s Announcement about the Situation of the Conference on the Feasibility of FDA NewDrug Application of Compound Danshen Dripping Pill, this article made a discussion about the reasons why the clinicaltrials of the dripping pill failed to pass the review and its application to FDA as a new drug to enter American market wasblocked, as well as the reasons for the different results of FDAⅡand Ⅲ clinical trials, the question about the authenticity ofthe TASLY’ s announcement and the confusing dosage forms between application and preparation. Some suggestions weregiven fi nally.