| 引用本文: |
杨平,林丹,曲建博,宋菊,阳长明.韩国植物药注册监管情况的介绍和思考[J].湖南中医药大学学报,2019,39(10):1289-封三[点击复制] |
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| 韩国植物药注册监管情况的介绍和思考 |
| 杨平,林丹,曲建博,宋菊,阳长明 |
| (国家药品监督管理局 药品审评中心, 北京 100022) |
| 摘要: |
| 本文对韩国植物药的法规与技术指南、注册分类、审批情况、监督管理及生产销售等进行介绍。韩国将植物药按照医学理论不同分为韩药和生药，对来自经典古籍处方的韩药产品可以减免临床试验，其重视对药材的标准化和规范化管理，用于汤剂的韩药材为许可管理。通过了解韩国植物药注册监管情况，提出应重视传统中药的研发特点和规律，重视人用经验，加强对药材及饮片的源头质量控制等。 |
| 关键词: 韩国 植物药 注册监管 中药 |
| DOI：10.3969/j.issn.1674-070X.2019.10.026 |
| 投稿时间：2019-09-03 |
| 基金项目: |
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| Introduction and Reflection on Registration and Supervision of Herbal Medicines in Korea |
| YANG Ping,LIN Dan,QU Jianbo,SONG Ju,YANG Changming |
| (Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China) |
| Abstract: |
| This paper introduced regulations, technical guidelines, registration classification, approval, supervision, production and sales of herbal medicines in Korea. Herbal medicines in Korea are divided into Korean medicines and crude medicines according to different medical theories. Clinical trials of Korean medicinal products from classic and ancient prescriptions can be reduced. Korea attaches importance to standardized management of medicinal materials. Korean medicinal materials used in decoctions are under license management. By understanding the registration and supervision of Korean herbal medicines, it is proposed that we should pay more attention to the research and development characteristics and rules of traditional Chinese materia medica, as well as application experiences in human body, and enhance source quality control of medicinal materials and decoction pieces. |
| Key words: Korea herbal medicines registration and supervision Chinese materia medica |
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