[Present situation and prospect of quality standardization of Chinese patent medicines].
This article reviews rectification and protection of Chinese patent medicines, establishment and improvement of the new drug approval, and historical evolution of the pharmacopoeia of the People's Republic of China. The article analyzes the present situation and the challenges of quality standardization of Chinese patent medicines in the new era. The article also points out strategies and guidelines to be taken to promote the globalization of Chinese patent medicines and compliance with the international standards.
Gao
Xue-Min
XM
Department of Chinese Herbal Formulae and Materia Medica, School of Preclinical Medicine, Beijing University of Chinese Medicine, Beijing 100029, China. zylab208@163.com
Zhang
Jian-Jun
JJ
Zhang
De-Qin
DQ
Wang
Jing-Xia
JX
Ou
Li-Na
LN
Chen
Shao-Hong
SH
D002681:China; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D004340:Drug Contamination; D004365:Drugs, Chinese Herbal / Q000008:administration & dosage / Q000592:standards*; D004366:Nonprescription Drugs / Q000592:standards*; D010602:Pharmacopoeias as Topic / Q000592:standards; D011786:Quality Control
D004365:Drugs, Chinese Herbal; D004366:Nonprescription Drugs