TCM-based new drug discovery and development in China

Wan-Ying Wu; Jin-Jun Hou; Hua-Li Long; Wen-Zhi Yang; Jian Liang; De-An Guo

doi:10.1016/S1875-5364(14)60050-9

TCM-based new drug discovery and development in China

Chin J Nat Med. 2014 Apr;12(4):241-50. doi: 10.1016/S1875-5364(14)60050-9.

Authors

Wan-Ying Wu¹, Jin-Jun Hou¹, Hua-Li Long¹, Wen-Zhi Yang¹, Jian Liang¹, De-An Guo²

Affiliations

¹ Shanghai Research Center for Modernization of Traditional Chinese Medicine and National Engineering Laboratory for TCM Standardization Technology, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai 201203, China.
² Shanghai Research Center for Modernization of Traditional Chinese Medicine and National Engineering Laboratory for TCM Standardization Technology, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai 201203, China. Electronic address: daguo@simm.ac.cn.

PMID: 24863348
DOI: 10.1016/S1875-5364(14)60050-9

Abstract

Over the past 30 years, China has significantly improved the drug development environment by establishing a series of policies for the regulation of new drug approval. The regulatory system for new drug evaluation and registration in China was gradually developed in accordance with international standards. The approval and registration of TCM in China became as strict as those of chemical drugs and biological products. In this review, TCM-based new drug discovery and development are introduced according to the TCM classification of nine categories.

Keywords: China; China Food and Drug Administration (CFDA); Drug development; Drug discovery; Regulatory classification; Traditional Chinese Medicine.

Publication types

Research Support, Non-U.S. Gov't
Review

MeSH terms

China
Drug Discovery / legislation & jurisprudence
Drug Discovery / standards*
Drugs, Chinese Herbal / analysis
Drugs, Chinese Herbal / standards
Medicine, Chinese Traditional / standards*

Substances

Drugs, Chinese Herbal