欧洲药典 European Pharmacopeia EP

《欧洲药典》为欧洲药品质量检测的惟一指导文献。所有药品和药用底物的生产厂家在欧洲范围内推销和使用的过程中，必须遵循《欧洲药典》的质量标准。《欧洲药典》由欧洲药品质量管理局（EDQM）负责出版和发行。
欧洲药品质量管理局EDQM
欧洲药品质量管理局（European Directorate for Quality Medicines& HealthCare,简称EDQM）隶属于欧洲议会。The EDQM (Council of Europe) is a key European Organisation involved in Harmonisation & Co-ordination of Standardisation, Regulation & Quality Control of Medicines, Blood Transfusion, Organ Transplantation, Pharmaceuticals and Pharmaceutical Care。 　　EDQM的愿景 　　通过建立下列产品与工作的高质量的标准成为保护公众健康的领导者：人用和兽用医疗产品， 　　输血和器官移植， 　　药品的安全与正确使用 我们的核心价值 　　作为一个组织，首先我们尊重公众健康、科技能力、诚实、客观和遵守欧洲委员会的基本原则。 　　我们致力于与地区、国家和国际机构、部门、组织和工业协会之间的合作，以获得相互之间更大的利益。 　　我们还将通过不断地改进，使我们的产品获得最高的质量，为我们的用户、合作者和顾员提供最大利益的服务。 　　EDQM的使命 　　EDQM的使命是致力于公众得到高质量药品和医疗保健的基本权利，通过以下方面促进和保障公众和动物的健康： 　　在编撰欧洲药典协议签署国建立和推行药品生产与质量控制的法定标准， 　　确保这些法定标准用于那些生产医疗产品的物质， 协调官方药品检验实验室网络的合作，分享成员国间的经验，并有效的利用有限的资源， 建立与输血有关的血液成分的采集、贮藏和使用，以及包括组织和细胞等的器官移植的伦理上的与质量上的标准， 与国家和国际组织合作，致力于消灭非法以及假冒的医药产品， 在欧洲提供包括药物治疗指南在内的安全使用药物的政策和示范。 概述欧洲药品质量管理和医疗保健局属欧洲委员会，总部设在斯特拉斯堡。 　　EDQM负责： 　　欧洲药典委员会的技术秘书处， 制备和分发化学对照品、生物标准品和标准图谱， 欧洲药典个论适用性认证申请的审评，以及相关现场审查的有关协调工作， 欧洲官方药品检验实验室网络的协调， 协调欧洲委员会成员国输血及器官移植工作的指导原则与建议的起草， 在药品制备与治疗领域内，协调与药品的质量与安全使用相关的程序与政策的起草，在假冒药品方面，协调风险预防和管理，并且在药品的供应方面，协调其分类， 出版和发行包括欧洲药典在内的所有EDQM的出版物。
Departments and Divisions
The European Pharmacopoeia Department (EPD) is responsible for the Secretariat of the European Pharmacopoeia Commission and for preparing the General Chapters and Monographs of the European Pharmacopoeia with the groups of experts. It also ensures the translation of the European Pharmacopoeia into both official languages of the Council of Europe: English and French and the translation of EDQM texts, covering a wide range of subjects related to pharmaceutical sciences and technology.

The Publications and Multimedia Department (DPM) is responsible for the production of EDQM publications, both printed and electronic versions, and for the development and maintenance of our databases. The DPM also provides internal IT support.

The Laboratory Department (DLab) contributes to the European Pharmacopoeia by providing analytical studies to develop its texts (General Chapters and Monographs,) and by establishing the corresponding reference standards. It is also involved in the establishment of WHO International Standards for Antibiotics (ISA) and International Chemical Reference Standards (ICRS). Finally, it contributes to the development of Proficiency Testing Scheme (PTS) studies for the General European OMCL Network and the World Health Organization (WHO).

The Biological Standardisation, Network of Official Medicines Control Laboratories (OMCL) and HealthCare Department (DBO) is responsible for the Biological Standardisation Programme (BSP), the Secretariat of the General European OMCL Network (GEON) and the Secretariat of the Steering Committees on Blood Transfusion (CD-P-TS) and Organ Transplantation (CD-P-TO). The DBO is also responsible for the Secretariat of the Steering Committee on Pharmaceuticals and Pharmaceutical Care (CD-P-PH) and the Secretariat of the Consumer Health Protection Committee (CD-P-SC) and their subordinate bodies.

The Certification of Substances Division (DCEP) is responsible for implementing the procedure for Certification of Suitability of the monographs of the European Pharmacopoeia (CEPs). The DCEP is also responsible for the organisation of onsite inspections of manufacturing sites and their follow-up, including the implementation of any subsequent action regarding the related CEPs and communication with the concerned authorities.

The Reference Standards and Samples Division (DRS) is responsible for the production, storage and dispatch of the European Pharmacopoeia Reference Standards, WHO International Standards for Antibiotics (ISA) and International Chemical Reference Standards (ICRS). It also procures samples, which are analysed in the process of elaborating the European Pharmacopoeia Monographs.

The Public Relations and Documentation Division (PRDD) is responsible for the EDQM's communications with its stakeholders, the general public, the media etc. It supplies information on, and answers questions about, the EDQM's activities. This includes maintenance of the website and production of EDQM catalogues, brochures and other public relations literature. The PRDD also organises EDQM events and ensures its participation in trade fairs and seminars. Finally, it is responsible for managing the archives and the EDQM library.

The Administration and Finance Division (DAF) is responsible for the administrative and financial management of the EDQM, which includes preparing and monitoring the budget, validating financial transactions and recruiting and developing staff and seconded personnel. These activities are carried out in close collaboration with the Council of Europe's Directorate General of Administration and Logistics (DLOG). The DAF is also responsible for processing customers' orders for EDQM products, issuing invoices and dealing with related queries.