| 欧洲药典适用性认证介绍 |
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| 引用本文： | 许明哲,杨昭鹏,李波.欧洲药典适用性认证介绍[J].中国药事,2011,25(12):1243-1246. |
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| 作者姓名： | 许明哲 杨昭鹏 李波 |
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| 作者单位： | 中国食品药品检定研究院,北京,100050 |
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| 摘 要： | 目的介绍欧洲药典适用性认证程序,为国内药品监管机构和原料药生产企业提供信息,促进我国原料药生产企业的国际化。方法通过查阅调研欧盟相关药品法规和与EDQM同行面对面的交流,详细了解欧洲药典适用性认证的组织机构和具体程序。结果与结论欧洲药典适用性认证程序在对原料药的质量控制有重要作用,加强了药典的监管力度,进一步保证了原料药的质量、安全性和有效性。
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| 关 键 词： | 欧洲药典适用性认证 欧洲药品健康管理局 原料药 质量控制 药典质量标准 |
Introduction of Certification of Suitability of Monographs of the European Pharmacopoeia |
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| Xu Mingzhe,Yang Zhaopeng,Li Bo.Introduction of Certification of Suitability of Monographs of the European Pharmacopoeia[J].Chinese Pharmaceutical Affairs,2011,25(12):1243-1246. |
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| Authors: | Xu Mingzhe Yang Zhaopeng Li Bo |
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| Institution: | Xu Mingzhe,Yang Zhaopeng and Li Bo (China National Institutes for Food and Drug Control,Beijing 100050) |
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| Abstract: | Objective To introduce the Certification of Suitability of Monographs of the European Pharmacopoeia to the domestic regulatory authorities and API manufacturers for their information and reference and to facilitate to form a global perspective for China API manufacturers.Methods By meaning of studying the documents and guidelines related with CoS and of face to face communication with EDQM counterparts have a deep understanding of the mission & organization and procedure of CoS.Results and Conclusion CoS pl... |
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| Keywords: | CoS EDQM API quality control Monograph |
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