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[中药资源评估的背景与总体设计]

[Background and overall design of Chinese medicine resources assessment].

作者信息

Guo Lan-Ping, Zhang Ze-Kun, Zhang Xiao-Bo, Yang Guang, Wang Hai-Nan, Huang Lu-Qi

机构信息

State Key Laboratory Breeding Base of Dao-di Herbs, National Resource Center for Chinese Materia Medica, China Academy of Chinese Medical Sciences, Beijing 100700, China.

Academy of Chinese Medical Sciences, Beijing 100700, China; 2.China National Drug Administration, Beijing 100620, China.

出版信息

Zhongguo Zhong Yao Za Zhi. 2018 Jul;43(14):2845-2849. doi: 10.19540/j.cnki.cjcmm.20180528.008.

Abstract

This paper comprehensively analyses the background and meaning of The Technological Guiding Principle for Assessment of Chinese Medicine Resources enacted by the former CFDA ( China Food and Drug Administration), moreover, it also points out that the Chinese medicine resources assessment with the purpose of guaranteeing the sustainable supplying capacity of Chinese medicine resources is the premise of new drug development; the Chinese medicine resources assessment which takes quality guarantee as the core is a significant action to promote the fixing of place of origin and quality-management antedisplacement for the traditional Chinese medicine industry; in this regard, the Chinese medicine resources assessment which aims at realizing the whole-process traceability is the key to building the high-quality modern traditional Chinese medicine brand. The Chinese medicine resources assessment which takes the classical prescription as the entry point is the embodiment of the protection of traditional Chinese medicine resources and international vision of regulation, which aims at clarifying the thinking for the relevant enterprises to carry out the Chinese medicine resources assessment. Base on the general thinking of ensuring that the "total amount of Chinese medicine resources is fixed and the supply is guaranteed", this paper clarifies two methods of Chinese medicine resources assessment: "family property assessment" of Chinese medicine resources based on "fixed total amount", "supply and demand balance assessment" of Chinese medicine resources based on "supply guarantee". In this regard, the basic strategy of "supply and demand balance assessment" of Chinese medicine resources based on "guaranteed supply" is put forward and it is believed that the resources assessment will lead to the significant adjustment of traditional Chinese medicinal materials production. It becomes the only way for the development of various Chinese medicine production enterprises to realize the comprehensive improvement of Chinese medicine quality, brand construction, the establishment of preferential price mechanism.

摘要

本文全面分析了原国家食品药品监督管理总局(CFDA)颁布的《中药资源评估技术指导原则》的背景和意义,同时指出,以保障中药资源可持续供应能力为目的的中药资源评估是新药研发的前提;以质量保障为核心的中药资源评估是推动中药产业产地固定和质量管理前置的重大举措;在此方面,以实现全过程追溯为目标的中药资源评估是打造高品质现代中药品牌的关键。以经典方剂为切入点的中药资源评估是对中药资源保护和监管国际视野的体现,旨在为相关企业开展中药资源评估厘清思路。基于确保“中药资源总量固定、供应保障”的总体思路,本文阐明了中药资源评估的两种方式:基于“总量固定”的中药资源“家底评估”、基于“供应保障”的中药资源“供需平衡评估”。在此基础上,提出了基于“保障供应”的中药资源“供需平衡评估”的基本策略,认为资源评估将引发中药材生产的重大调整。实现中药质量全面提升、品牌建设、建立优惠价格机制是各类中药生产企业发展的必由之路。

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