| 聂黎行,马双成,张颖,王海南.国际植物药监管合作组织（IRCH）的发展及对我国植物药监管的启示[J].中国药事,2017,(11):1281-1284 |
| 国际植物药监管合作组织（IRCH）的发展及对我国植物药监管的启示 |
| Development of International Regulatory Cooperation for Herbal Medicines and Its Enlightenment to Administration of Herbal Medicines in China |
| 投稿时间：2017-01-10 |
| DOI：10.16153/j.1002-7777.2017.11.010 |
| 中文关键词: 国际植物药监管合作组织 世界卫生组织 植物药 监督管理 国际合作 |
| 英文关键词: International Regulatory Cooperation for Herbal Medicines World Health Organization (WHO) herbal medicines administration international cooperation |
| 基金项目:国家自然科学基金（编号81303194）；国家十二五“重大新药创制”专项（编号2014ZX09304307-002） |
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| 中文摘要: |
| 目的：介绍国际植物药监管合作组织（IRCH）发展情况，为进一步做好我国植物药的监督和管理提供参考。方法：对该组织的发展历程、成员和构架、工作形式及最新一届年会的情况进行介绍，提出对我国植物药监管的启示。结果与结论：中国是该组织的第一批成员国，一直积极参与国际植物药监管合作组织相关工作。参与IRCH活动，不仅可展示国家食品药品监督管理总局在完善中药注册管理法规体系方面取得的成绩，促进中国食品药品检定研究院领导的第二工作组的交流与合作；还可了解各国植物药掺假的现状和监管手段，更好地推动未来的植物药监管工作。 |
| 英文摘要: |
| Objective: To introduce the development of International Regulatory Cooperation for Herbal Medicines (IRCH) and to provide references for administration of herbal medicines in China. Methods: The development, membership and framework, ways of working and general information of the latest annual meeting of IRCH were introduced. The enlightenment to administration of herbal medicines in China was also illustrated. Results and Conclusion: China is one of the frst member countries of the organization and has always actively participated in the work related to IRCH, which not only showed China Food and Drug Administration (CFDA)'s achievements in improving the legal system for registration of traditional Chinese medicine (TCM) but also promoted the exchange and cooperation of working group Ⅱ organized by National Institutes for Food and Drug Control (NIFDC). Furthermore, the situation and control of adulteration in herbal medicines from IRCH members were studied to better promote the future administration of herbal medicines. |
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