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歐洲藥典 European Pharmacopeia EP

《歐洲藥典》為歐洲藥品質(zhì)量檢測的惟一指導(dǎo)文獻(xiàn)。所有藥品和藥用底物的生產(chǎn)廠家在歐洲范圍內(nèi)推銷和使用的過程中，必須遵循《歐洲藥典》的質(zhì)量標(biāo)準(zhǔn)?！稓W洲藥典》由歐洲藥品質(zhì)量管理局（EDQM）負(fù)責(zé)出版和發(fā)行。
歐洲藥品質(zhì)量管理局EDQM
歐洲藥品質(zhì)量管理局（European Directorate for Quality Medicines& HealthCare,簡稱EDQM）隸屬于歐洲議會(huì)。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 　　通過建立下列產(chǎn)品與工作的高質(zhì)量的標(biāo)準(zhǔn)成為保護(hù)公眾健康的領(lǐng)導(dǎo)者：人用和獸用醫(yī)療產(chǎn)品， 　　輸血和器官移植， 　　藥品的安全與正確使用 我們的核心價(jià)值 　　作為一個(gè)組織，首先我們尊重公眾健康、科技能力、誠實(shí)、客觀和遵守歐洲委員會(huì)的基本原則。 　　我們致力于與地區(qū)、國家和國際機(jī)構(gòu)、部門、組織和工業(yè)協(xié)會(huì)之間的合作，以獲得相互之間更大的利益。 　　我們還將通過不斷地改進(jìn)，使我們的產(chǎn)品獲得最高的質(zhì)量，為我們的用戶、合作者和顧員提供最大利益的服務(wù)。 　　EDQM的使命 　　EDQM的使命是致力于公眾得到高質(zhì)量藥品和醫(yī)療保健的基本權(quán)利，通過以下方面促進(jìn)和保障公眾和動(dòng)物的健康： 　　在編撰歐洲藥典協(xié)議簽署國建立和推行藥品生產(chǎn)與質(zhì)量控制的法定標(biāo)準(zhǔn)， 　　確保這些法定標(biāo)準(zhǔn)用于那些生產(chǎn)醫(yī)療產(chǎn)品的物質(zhì)， 協(xié)調(diào)官方藥品檢驗(yàn)實(shí)驗(yàn)室網(wǎng)絡(luò)的合作，分享成員國間的經(jīng)驗(yàn)，并有效的利用有限的資源， 建立與輸血有關(guān)的血液成分的采集、貯藏和使用，以及包括組織和細(xì)胞等的器官移植的倫理上的與質(zhì)量上的標(biāo)準(zhǔn)， 與國家和國際組織合作，致力于消滅非法以及假冒的醫(yī)藥產(chǎn)品， 在歐洲提供包括藥物治療指南在內(nèi)的安全使用藥物的政策和示范。 概述歐洲藥品質(zhì)量管理和醫(yī)療保健局屬歐洲委員會(huì)，總部設(shè)在斯特拉斯堡。 　　EDQM負(fù)責(zé)： 　　歐洲藥典委員會(huì)的技術(shù)秘書處， 制備和分發(fā)化學(xué)對(duì)照品、生物標(biāo)準(zhǔn)品和標(biāo)準(zhǔn)圖譜， 歐洲藥典個(gè)論適用性認(rèn)證申請(qǐng)的審評(píng)，以及相關(guān)現(xiàn)場審查的有關(guān)協(xié)調(diào)工作， 歐洲官方藥品檢驗(yàn)實(shí)驗(yàn)室網(wǎng)絡(luò)的協(xié)調(diào)， 協(xié)調(diào)歐洲委員會(huì)成員國輸血及器官移植工作的指導(dǎo)原則與建議的起草， 在藥品制備與治療領(lǐng)域內(nèi)，協(xié)調(diào)與藥品的質(zhì)量與安全使用相關(guān)的程序與政策的起草，在假冒藥品方面，協(xié)調(diào)風(fēng)險(xiǎn)預(yù)防和管理，并且在藥品的供應(yīng)方面，協(xié)調(diào)其分類， 出版和發(fā)行包括歐洲藥典在內(nèi)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.