《欧洲药典》适用性认证组织机构介绍  

Introduction of Organization for Certification of Suitability of Monographs of the European Pharmacopoeia

作　　者：田学波[1] 祁文娟[1] 许明哲[1] 杨昭鹏[1] 

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《中国药事》2012年第9期1017-1019,1026,共4页Chinese Pharmaceutical Affairs

摘　　要：目的介绍《欧洲药典》适用性认证程序的工作职责和组织机构,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欧洲药品健康管理局(EDQM)同行面对面的交流,详细了解《欧洲药典》适用性认证的工作内容、规章制度和组织机构。结果与结论欧洲有专门的组织机构负责《欧洲药典》适用性认证程序,具有专门的认证步骤和要求,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。Objective To introduce the organization and its structure and duties for Certification of Suitability of Monographs of the European Pharmacopoeia （COS） and to provide relative information for domestic regulatory authorities and API manufacturers, in order to improve the internationalization of domestic API manufacturers. Methods By studying the documents and guidelines related with CoS and through face to face communications with EDQM counterparts, a deep understanding was achieved of the content, organization and procedure of CoS. Results and Conclusion There is a specified agency responsible for CoS. With the implementation of CoS, the quality, safety and efficacy of API can be further controlled and ensured.

关 键 词：《欧洲药典》适用性认证 认证组织机构 原料药 质量控制 药典质量标准 

分 类 号：R95[医药卫生—药学]