How to establish precise proprietary Chinese medicine in post-marketing reappraisal?
Journal Title: Traditional Medicine Research - Year 2017, Vol 2, Issue 4
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.
Authors and Affiliations
Tian Ran, Dai Liang, Shang Hong-Cai, Li You-Ping, Bian Zhao-Xiang
Keywords
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- EP ID EP45249
- DOI 10.12032/TMR201708054
- Views 273
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