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Traditional Medicine Research  2017, Vol. 2 Issue (4): 155-160    DOI: 10.12032/TMR201708054
Post-marketing Reappraisal     
How to establish precise proprietary Chinese medicine in post-marketing reappraisal?
Tian Ran1,2, Dai Liang1,2, Shang Hong-Cai3, Li You-Ping4, Bian Zhao-Xiang1,2,*()
1Hong Kong Chinese Medicine Clinical Study Centre of HKBU, Hong Kong, China
2School of Chinese Medicine of HKBU, Hong Kong, China
3Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China
4Chinese Cochrane Center of West China Hospital, Sichuan University, Sichuan, China.
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Highlights

This paper introduced a new concept “precise proprietary Chinese medicine” with six detailed steps to facilitate the post-marketing reappraisal.

Editor’s Summary

The post-marketing reappraisal of Chinese medicine is a systematic project rather than a pile of simply isolated research about the drug efficacy and safety.

Abstract

The clinical efficacy and safety of proprietary Chinese medicine has become a more prevailing public health concern. The China Food and Drug Administration has pushed drug companies to conduct post-marketing reappraisal for proprietary Chinese medicine to provide additional evidence supporting the efficacy and safety of these medicine. In this paper, we propose a reappraisal protocol called “precise proprietary Chinese medicine” to precisely i) define the therapeutic aim; ii) design the protocol; iii) control the quality of proprietary Chinese medicine; iv) implement the protocol in the trial; v) study the mechanism-of-action of the proprietary Chinese medicine and vi) describe the indications of the proprietary Chinese medicine. We hope that these steps facilitate the post-marketing reappraisal of proprietary Chinese medicine.



Key wordsTraditional Chinese medicine      Post-marketing reappraisal      Precise Chinese medicine     
Published: 05 October 2017
Corresponding Authors: Bian Zhao-Xiang     E-mail: bianzxiang@gmail.com
Cite this article:

Tian Ran, Dai Liang, Shang Hong-Cai, Li You-Ping, Bian Zhao-Xiang. How to establish precise proprietary Chinese medicine in post-marketing reappraisal?. Traditional Medicine Research, 2017, 2(4): 155-160. doi: 10.12032/TMR201708054

URL:

https://www.tmrjournals.com/tmr/EN/10.12032/TMR201708054     OR     https://www.tmrjournals.com/tmr/EN/Y2017/V2/I4/155

Figure 1 Compositions of precise proprietary Chinese Medicine
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