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.
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.
Chin J Nat Med. 2014 Apr;12(4):241-50. doi: 10.1016/S1875-5364(14)60050-9.
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.
在过去的 30 年中，中国通过建立一系列新药审批监管政策，极大地改善了药物开发环境。中国新药评价和注册监管体系逐步按照国际标准发展，中药的审批和注册与化学药品和生物制品一样严格。本文按照中药九类分类，介绍了基于中药的新药发现和开发。
