Title of article :
Editorial: How to establish precise proprietary Chinese medicine in post-marketing reappraisal?
Author/Authors :
Tian ، Ran - Hong Kong Baptist University , Dai ، Liang - Hong Kong Baptist University , Shang ، Hong-Cai - Beijing University of Chinese Medicine , Li ، You-Ping - Sichuan University , Bian ، Zhao-Xiang - Hong Kong Baptist University
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 postmarketing 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 mechanismofaction of the proprietary Chinese medicine and vi) describe the indications of the proprietary Chinese medicine. We hope that these steps facilitate the postmarketing reappraisal of proprietary Chinese medicine.
Keywords :
Traditional Chinese medicine , Post , marketing reappraisal , Precise Chinese medicine
Journal title :
Traditional Medicine Research
Journal title :
Traditional Medicine Research