A Proposal of the Establishment of Technology System of Review and Registration in Conformity with the Characteristics Traditional Chinese Medicine

VernacularTitle:关于构建符合中药特点的审评注册技术体系的几点建议
Author: Zhang BOLI
Keywords: Characteristics of traditional Chinese medicine; new drugs; review and registration; technology system
From: World Science and Technology-Modernization of Traditional Chinese Medicine 2016;18(12):2031-2033
CountryChina
Language:Chinese
Abstract: Thanks to the improving new drug approval system and the wide application of new technology in China,the development of traditional Chinese medicine (TCM) meets the golden opportunity at the best conditions.In the further research of new drugs,effective data mining of ancient literatures and clinical medication experience need paying more attention supported by research data of clinical efficacy of new Chinese drugs,as it is generally recognized,for the establishment of the approval system of syndrome types.In addition,we should prudently value the safety issues on TCM and improve the classification and registration of new Chinese drugs and drug approval in the future.Therefore,the research and development of modern drugs,evaluation standard and review experience of new Chinese drugs in the recent three decades need integrating for the establishment of the improvement of the technology system of drug review and registration in conformity with the characteristics of TCM of great significance in the clinical service and industrial development of TCM.