中国中药杂志

2020, v.45(16) 4004-4008

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关于中药注册分类的思考和建议
Thoughts and suggestions on registration and classification of traditional Chinese medicines

唐健元;
TANG Jian-yuan;Hospital of Chengdu University of Traditional Chinese Medicine;

摘要(Abstract):

该文全面回顾了自我国药品监管机构成立以来的中药注册分类变迁历史,并提出相关建议。虽然中国药品监督管理机构已走过22个年头,但整个监管体系是基于中国当时的仿制药工业基础和对国外监管机构的简单学习中不断摸索总结中逐步建立起来的,而中药注册监管在一定程度上也受到这期间一些不成熟的监管思路的影响。笔者通过对近期新发布的《药品管理法》和《药品注册管理办法》的学习体会,对中药注册分类提出一些个人思考,供社会各界讨论,以期广大业内专家与监管机构一道共同探讨完善中药注册管理的相关制度。
In this paper, we reviewed the history of the registration and classification changes of traditional Chinese medicines(TCM) since the establishment of China′s drug regulatory agency, and put forward relevant suggestions. Although China′s drug regulatory agency has gone through 22 years, the whole regulatory system was gradually built on the basis of the generic pharmaceutical industry at that time and through continuous exploration and summary of simply experience from foreign regulatory agencies. To a certain extent, the supervision of TCM drugs was also affected by some immature supervision ideas during this period. Based on the newly issued Drug Administration Law and Provisions for Drug Registration, the author puts forward some personal thoughts on the classifications of TCM drug registration. It is hoped that experts in the industry and regulatory agencies will work together to explore and improve the relevant system of TCM registration administration.

关键词(KeyWords): 中药;注册监管;监管机构
Chinese medicine;registration administration;regulatory agency

Abstract:

Keywords:

基金项目(Foundation): 四川省科技厅2020第一批科技攻关应急项目(2020YFS0012,2020YFS0013);; 成都市科技局2020市财政科技项目(第一批)(2020-YF05-00333-SN);; 成都中医药大学基金项目(XGZX2001,XGZX2002)

作者(Author): 唐健元;
TANG Jian-yuan;Hospital of Chengdu University of Traditional Chinese Medicine;

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