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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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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.


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:
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

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Figure 1 Compositions of precise proprietary Chinese Medicine
1.   China Food and Drug Administration. Annual report on drug safety surveillance (2015). 2016 July 13th. Available from: URL:.
2.   China Food and Drug Administration. Response to No. 1628 recommendation of Third Session of the Twelfth National People’s Congress (recommendation about promoting TCM modernization). 2016 September 2nd. Available from: URL:.
3.   Guo XX, Yan M, Wu Y, et al.How to understand post-marketing reappraisal. Chin J New Drugs 2000, 9(8): 513-515.
4.   Yan M, Wu Y, Wang LM, et al.The current situation and thinking of the drug post-marketing reappraisal. Chin J New Drugs 1999, 8(7): 433-436.
5.   Chan AW, Tetzlaff JM, Altman DG, et al.SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med 2013, 158(3): 200-207.
doi: 10.7326/0003-4819-158-3-201302050-00583 pmid: 23295957
6.   Chan AW, Tetzlaff JM, G?tzsche PC, et al.SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ 2013, 346: e7586.
doi: 10.1136/bmj.e7586 pmid: 23303884
7.   He W, Xie YM, Wang Y.Post-marketing reappraisal of Chinese medicines should concern the re-evaluation of syndromes. J Chin Mat Med 2010, (11): 1498-1500.
8.   Zhou H.Introduction about the first US herbal medicine Veregen? and its implication for traditional Chinese medicine research development. Tradit Chin Drug Res Clin Pharm 2008, 19(4): 326-328.
9.   He Y, Ye ZL, Zhao L, et al.Analysis on the differences of quality standards of Chinese medicine/herbal medicine/tradition herbal medicine in China, United States and Europe. Chin Tradit Herbal Drugs 2012, 43(1): 182-186.
10.   Tian SL.Development and supplementation of standard operating procedures in drug clinical trials. Chin J Med Guide 2003, 5: 308-309.
11.   Huang M,Tian SL,Chen X, et al.Practical guide for standard practice for clinical trials of drugs (1st edition). Guangdong Sci Technol Press 2004: 43-48.
12.   Hu DD, Han QB, Zhong LLD, et al.Simultaneous determination of ten compounds in rat plasma by UPLC-MS/MS: Application in the pharmacokinetic study of Ma-Zi-Ren-Wan. J Chromatogr B 2015, 1000: 136-146.
doi: 10.1016/j.jchromb.2015.07.003 pmid: 26231677
13.   Wang HY, Wang X, Zhu WT.Comparison of package insert between Chinese traditional patent medicine and America drug. Chin J Drug Evalu 2013, 30(2): 73-76.
14.   He W, Xie YM, Wang YY.Reflections on some problems in Chinese re-evaluation of traditional Chinese medicine. Chin J Chin Mat Med 2010, 12: 1641-1643.
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