《欧洲药典》适用性认证组织机构介绍

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.

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

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.