Case Study of Compound Traditional Chinese Medicine Globalization
- VernacularTitle:复方中药国际化开发实例分析
- Author:
He SUN
1
;
Zhixin GUO
;
Lingyan LI
;
Shunnan ZHANG
;
Yi HE
;
Xiaohui MA
;
Genbei WANG
;
Ping WANG
;
Liu YANG
Author Information
- Keywords: Compound Traditional Chinese Medicine; Compound Danshen Dripping Pill; T89; globalization; FDA application
- From: World Science and Technology-Modernization of Traditional Chinese Medicine 2017;19(6):914-923
- CountryChina
- Language:Chinese
- Abstract: Compound Traditional Chinese Medicine (CTCM) applying for FDA approval as botanical drug is a systemic and innovative work.Compound Danshen Dripping Pill (T89) is the first CTCM completed FDA global multi-center Phase Ⅲ clinical trial,which has become a benchmark for TCM globalization.Extensive experiences have been accumulated through the 20 years' research and development.Tasly fully considered the characteristics of CTCM while complying with FDA regulations during the entire application process.In which,product indication was clearly defined and agreed,clinical trial protocol was scientifically and innovatively designed with gold standard,phase Ⅱ study was well completed,SPA for phase Ⅲ study was obtained,and eventually the global multi-center phase Ⅲ study was successfully completed.In order to better support T89's application,Tasly conducted series of additional studies and introduced many innovations,such as drug-drug interaction study for TCM,finger printing study for CTCM,quality consistency study,biological assay study and etc.Globalization of T89 is not only a product creating history,but also a process for Tasly and the US FDA working together to continuously innovate and create history in innovating modern TCM standards,improving industrial chain GMP system for botanical drugs,making technical breakthroughs,exploring regulatory pathways and increasing product value.It represents the national power and historical progress in medicine.
