欧洲官方药品质量控制实验室联盟的功能和职责

Function and Responsibility of European Official Medicines Control Laboratories Network

目的:介绍欧洲官方药品质量控制实验室联盟的功能和职责,为我国药检系统的建设和发展提供信息和借鉴,进一步为我国药品监管提供技术支持和保障。方法:通过调研和查阅欧洲药品健康管理局(EDQM)系列发布的关于欧洲官方药品质量控制实验室联盟的章程、制度和技术指导原则,以及与欧洲药品质量控制实验室同行面对面的交流,全面详细了解欧洲官方药品质量控制实验室联盟的功能和职责。结果与结论:欧洲官方药品质量控制实验室联盟在保证欧洲药品质量、提升欧洲药典质量标准方面具有完备的功能和职责,建立起紧密的协作关系,为欧洲的药品监管提供了重要的制度保证。对我国药检系统的深入建设具有很强的借鉴意义。

Objective: To introduce the function and responsiblilty of European Official Medicines Control Laboratories(OMCL) Network, to provide information and references for the construction and development of drug control systems in China and to provide technical support and gruarantee for drug regulation in China.Methods: Statutes, systems and technical guidelines of European OMCL Network issued by European Directorate for the Quality of Medicines(EDQM) were analyzed and reviewed. The function and responsibility of the European OMCL Network were fully understood through face-to-face communication with staff of the European OMCL Network. Results and Conclusion: Eurpoean OMCL Network has overall responsibility and appropriate function to ensure the drug quality in European market and to improve the quality standards of European Pharmacopoeia. As a result, Eurpoean OMCL Network has established a close cooperative relationship and provided an important institutional guarantee for drug regulation in Europe and has a strong referential value for the further construction of drug control systems in China.