欧洲药典简介

2017-08-10 15:32:10.0

  第8版的实施日期为2014年1月1日;在接下来的3年,本版本将添加8篇增补,里面包含欧洲药典委员会会议上采纳的内容。和以往一样,该版本以两种欧洲议会官方语言(即英语和法语)发行,包括印刷版和电子版(在线和USB密匙)。值得注意的是,某些成员国开展了全国性或区域性转化,将它们融合到了本国药典中。

8.0版欧洲药典适用地区(成员国)

  欧洲药典是根据按公约草案(欧洲条约序列号134)修订的欧洲药典起草公约(欧洲条约序列号50)(“公约”)条款,由欧洲议会的主持制定的,由37个成员国(奥地利、比利时、波斯尼亚和黑塞哥维那、保加利亚、克罗地亚、塞浦路斯、捷克共和国、丹麦、爱沙尼亚、芬兰、法国、德国、希腊、匈牙利、冰岛、爱尔兰、意大利、拉脱维亚、立陶宛、卢森堡、马其他、黑山、荷兰、挪威、波兰、葡萄牙、罗马尼亚、塞尔维亚、斯洛伐克共和国、斯洛文尼亚、西班牙、瑞典、瑞士、“前南斯拉夫马其顿共和国”、土耳其、乌克兰和英国)政府和欧盟签字生效。

  根据公约第5条任命的欧洲药典委员会(“委员会”)负责欧洲药典的编制。该委员会由缔约方指派代表团组成。每个代表团由挑选的不超过3名能够胜任委员会职能范围内事物的成员组成。

欧洲药典观察员

  按照议事规则,来自非成员国和国际组织的观察员获准参加委员会会议。目前获准的观察员来自:阿尔巴尼亚、阿尔及利亚、阿根廷、亚美尼亚、澳大利亚、巴西、加拿大、中国、格鲁吉亚、以色列、马达加斯加、马来西亚、摩尔多瓦、摩洛哥、白俄罗斯共和国、几内亚共和国、哈萨克斯坦共和国、新加坡共和国、俄罗斯联邦、塞内加尔、叙利亚、突尼斯、美利坚合众国和世界卫生组织。

  公约是公开的,以供欧洲国家签字;使用委员会的工作方法,观察员身份可以有助于熟悉有意成为签署国的欧洲国家。委员会认识到,从制药行业供应链全球化的角度看,与欧洲外国家建立关系是必要的。通过促进监管合作和交换信息和工作文件,非欧洲国家的观察员身份有助于培养这种关系。

委员会职责

根据按协议修订的公约第6条确立委员会的职能:

第6条

“服从现有公约第4条规定,委员会的职能包括:

(a)确定适用于欧洲药典起草的一般原则;

(b)确定用于该目的的分析方法;

(c)安排编写和批准欧洲药典要包含的各论;

(d)推荐设定必须在缔约方的疆域内开展欧洲药典相关技术特征决策的期限。”

  欧洲议会下属欧洲药品质量管理局(EDQM)通过设立科学秘书处为委员会起草和修订欧洲药典文本提供支持。此外,它还负责确立、制定、监测和分发应用各论时所需的参考保标准。EDQM也热衷于许多与保护公众健康相关的其它领域,例如验证特定来源的药用活性成分的质量和生物标准化。

  根据公约条款,缔约方承诺采取必要的措施确保欧洲药典的各论必须成为它们适用于各自疆域内的官方标准。

欧洲药典的目的

  欧洲药典的目的是根据认可的药品及其成分质量的通用标准规定提升公众健康。这些标准适合作为患者安全使用药品的依据。此外,这些标准为欧洲和欧洲以外地区医药产品的自由流通提供了便利。

  设计欧洲药典各论和其它章节适合以下方面的需要:

——监管当局;

——那些从事医药产品及其成分质量控制的人员;

——医药产品及其成分的生产商。

  欧洲药典在国际上被广泛应用。国际贸易的全球化和扩张对全球药品质量标准研制的需求不断增长,因此委员会与全球所有的药典用户进行紧密的合作。

欧洲药典的一般原则

  凡例中给出了欧洲药典文本解读的通则。以下信息也应予以注意。

  按照规程和EDQM网站上可用的技术导则,制定欧洲药典各论起草中应用的通则。在无完整追溯性应用情况下,及时对应用的通则进行修订,因此已出版的各论可能不会始终遵循最新的建议,但是只要鉴别出对公众健康有影响的问题,就要对各论进行修订。

  人们认识到,通则还用于除欧洲药典各论之外的其它地方;在这些情况下,建议用户查阅相关的技术导则,其中给出了关于很多方法应用的广泛信息。

工作流程

  工作计划(起草新编各论或通用章节或现有文本修订)由委员会在三次年度会议中的一次会议上决定。一般而言,只要有2个成员国表达起草各论的意愿,委员会都会在工作计划中添加该事项。在EDQM网站上以及欧洲药典在线论坛中发布工作计划变更情况。还将信息提供给在秘书处注册的行业协会和生产商通信联络人。邀请利益攸关方与秘书处联系以讨论他们希望参与这项工作的事宜。

验证流程

  已确立了欧洲药典关于给定来源的产品质量控制的各论适用性认证的程序(见公共健康委员会(局部协议)决议AP-CSP(07)或任何随后的修订,可以从EDQM及其网站上获取),有助于上市许可申请中各论的应用。认证程序还应用于草药、草药制剂和传染性海绵状脑病(TSE)风险。EDQM仅对在恰当的质量体系下生产的物质发放适用性证书。关于已出版的各论,授予证书。可以从秘书处和EDQM网站上获取这种方案运作的详细情况。可以从EDQM网站上在线获取所授予证书的每日更新清单,包括无效的或暂缓生效的证书。

印刷

  欧洲药典的官方版本用英语和法语形式发行,包括每年3次增补的书籍形式和电子格式(在线,包括平板电脑版和使用USB插入设备)。

论坛

  Pharmeuropa——欧洲药典论坛,作为各论起草的一种辅助手段以及获取药典和相关事宜信息的一种工具,每年发布四次。

欧洲药典论坛生物版和科技论文——一份使用数目服务索引的出版物,包括与EDQM生物标准化计划中的生物学参考制剂设立和生物学方法验证、药物分析各个方面和其它欧洲药典相关学科相关的科学论文。自2012年起,两种出版物都只能通过在线免费获取,陆续发布了个体草案和科学论文。

网站

  可在EDQM网站上找到关于活动和欧洲药典很多其它方面的信息。

药典的执行

  在委员会的推荐下,欧洲议会下属欧洲药品和药学服务委员会达成决议(局部协议),设定了各论的实施日期。该日期通常是批准后1年和发布后大约6个月。如果早于欧洲药典或增补的下一个发布日期实施各论,欧洲药品和药学服务委员会决议提供需要实施的完整文本。该文本还在在线欧洲药典中发布以供参考,并且作为决议的一部分张贴于EDQM网站。

药典的修订

  必要时遵循委员会的决策,对欧洲药典的各论和其它文本内容进行修订。欧洲药典在线论坛中发布修订建议。由代表团、委员会的主席或专家组组长提交各论修订建议。来自其它各方的修订请求应通过成员国的国家药典当局提交,如果无法做到这一点时,则通过HelpDesk提交给EDQM。各论修订建议必须具有足够的数据资料以证明修订需求的正当性。


About EP

2015-09-15 23:58:15.0

The implementation date for the 8th Edition is 1 January 2014 and this edition will, over the next 3 years, be augmented with 8 supplements containing the texts adopted at the sessions of the European Pharmacopoeia Commission. As ever, it is published in the 2 official languages of the Council of Europe, i.e. English and French, both as a printed version and electronically (online and on a USB key). It is noteworthy that certain member states undertake national or regional translations, which they incorporate into their own national pharmacopoeias.

Member States of the 8th Edition the European Pharmacopoeia Application

The European Pharmacopoeia is prepared under the auspices of the Council of Europe in accordance with the terms of the Convention on the Elaboration of a European Pharmacopoeia (European Treaty Series No. 50) (‘the Convention’) as amended by the protocol to the Convention (European Treaty Series No. 134), signed by the governments of 37 member states (Austria, Belgium, Bosnia and Herzegovina, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Montenegro, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovak Republic, Slovenia, Spain, Sweden, Switzerland, ‘the former Yugoslav Republic of Macedonia’, Turkey, Ukraine and United Kingdom) and by the European Union.

The preparation of the European Pharmacopoeia is the responsibility of the European Pharmacopoeia Commission (‘the Commission’), appointed in accordance with article 5 of the Convention. It is composed of delegations appointed by the contracting parties. Each delegation consists of not more than 3 members chosen for their competence in matters within the functions of the Commission.

Observers of the European Pharmacopoeia 8th Edition

Observers from non-member states and international organisations are admitted to sessions of the Commission in accordance with the Rules of Procedure. Observers are at present admitted from: Albania, Algeria, Argentina, Armenia, Australia, Brazil, Canada, China, Georgia, Israel, Madagascar, Malaysia, Moldova, Morocco, Republic of Belarus, Republic of Guinea, Republic of Kazakhstan, Republic of Singapore, Russian Federation, Senegal, Syria, Tunisia, United States of America and the World Health Organization.

The Convention is open for signature by European countries and observer status can serve to familiarise European countries intending to become signatories with the working methods of the Commission. The Commission recognises that relations with countries outside Europe are essential in view of the globalisation of the supply chain for pharmaceuticals. Observer status for non-European countries helps to foster these relations by facilitating regulatory partnerships and the exchange of information and working documents.

The Functions of the Commission

The functions of the Commission established by article 6 of the Convention as amended by the protocol are:

Article 6

“Subject to the provision of Article 4 of the present Convention, the functions of the Commission shall be:

(a) to determine the general principles applicable to the elaboration of the European Pharmacopoeia;

(b) to decide upon methods of analysis for that purpose;

(c) to arrange for the preparation of and to adopt monographs to be included in the European Pharmacopoeia and;

(d) to recommend the fixing of the time limits within which its decisions of a technical character relating to the European Pharmacopoeia shall be implemented within the territories of the contracting parties.”

The European Directorate for the Quality of Medicines & HealthCare (EDQM) of the Council of Europe supports the Commission in the elaboration and revision of texts of the European Pharmacopoeia by providing the scientific secretariat. In addition, it is responsible for the establishment, production, monitoring and distribution of reference standards needed when applying the monographs. The EDQM is also active in a number of other areas related to the protection of public health, for example in certifying the quality of active pharmaceutical ingredients from specific sources and in biological standardisation.

In accordance with the terms of the Convention, the contracting parties undertake to take the necessary measures to ensure that the monographs of the European Pharmacopoeia shall become the official standards applicable within their respective territories.

The Purpose of the European Pharmacopoeia

The purpose of the European Pharmacopoeia is to promote public health by the provision of recognised common standards for the quality of medicines and their components. Such standards are to be appropriate as a basis for the safe use of medicines by patients. In addition, their existence facilitates the free movement of medicinal products in Europe and beyond.

European Pharmacopoeia monographs and other texts are designed to be appropriate to the needs of:

– regulatory authorities;

– those engaged in the quality control of medicinal products and their components;

– manufacturers of medicinal products and their components.

The European Pharmacopoeia is widely used internationally. As globalisation and expansion in international trade present a growing need to develop global quality standards for medicines, the Commission works closely with all users of the Pharmacopoeia worldwide.

General Rules of the European Pharmacopoeia

General rules for interpretation of the texts of the European Pharmacopoeia are given in the General Notices. The following information should also be noted.

The general principles applied in the elaboration of monographs of the European Pharmacopoeia are laid down in procedures and in technical guides available on the EDQM website. The principles applied are revised from time to time without complete retrospective application so that monographs already published may not always follow the latest recommendations, but wherever an issue with an impact on public health is identified, monographs are revised.

It is recognised that general chapters are also used elsewhere than in the monographs of the European Pharmacopoeia; in these circumstances users are recommended to consult the relevant technical guide, which gives extensive information on the application of many of the methods.

The Work Programme

The work programme (elaboration of new monographs or general chapters or revision of existing texts) is decided by the Commission at one of the three annual sessions. In general, whenever 2 member states express a wish to elaborate a monograph, the Commission adds the item to the work programme. Changes to the work programme are published on the EDQM website and in Pharmeuropa Online. Information is also provided to industry associations registered with the secretariat and to manufacturers’ liaison contacts. Interested parties are invited to contact the secretariat for any items where they wish to be involved in the work.

The Certification Procedure

A procedure for the certification of suitability of monographs of the European Pharmacopoeia with respect to quality control of a product from a given source has been established (see Public Health Committee (Partial Agreement) Resolution AP-CSP (07) 1 or any subsequent revision, available from the EDQM and on its website) as an aid to the use of monographs in applications for marketing authorisation. The certification procedure also applies to herbal drugs, herbal drug preparations and transmissible spongiform encephalopathy (TSE) risk. Certificates of suitability are issued by the EDQM only for substances produced under a suitable quality system. Certificates are granted with respect to published monographs. Details of the operation of this scheme are available from the secretariat and on the EDQM website. A daily updated list of certificates granted is available online on the EDQM website, including voided or suspended certificates.

Printing

The official version of the European Pharmacopoeia is available in English and in French, in the form of a book with 3 supplements per year, and in electronic format (online, including a tablet version, and on USB stick).

Forum

Pharmeuropa, the European Pharmacopoeia forum, is published 4 times per year as an aid for the elaboration of monographs and as a vehicle for information on pharmacopoeial and related matters. Pharmeuropa Bio & Scientific Notes, a publication indexed by bibliographic services, includes scientific papers related to the establishment of biological reference preparations and validation of biological methods within the Biological Standardisation Programme of the EDQM, and to various aspects of pharmaceutical analysis and other subjects relevant to the European Pharmacopoeia.Since 2012, both publications are only available online, free of charge, and individual drafts and scientific papers are published on an ongoing basis

Website

Information on activities and many other aspects of the European Pharmacopoeia is to be found on the EDQM website.

Implement of the European Pharmacopoeia

The date on which monographs are to be implemented is fixed by a resolution of the European Committee on Pharmaceuticals and Pharmaceutical Care (Partial Agreement) of the Council of Europe, following a recommendation by the Commission. This date is usually 1 year after adoption and about 6 months after publication. Where a monograph is to be implemented at a date earlier than the next publication date of the European Pharmacopoeia or a supplement, a resolution of the European Committee on Pharmaceuticals and Pharmaceutical Care gives the full text to be implemented. The text is also published in Pharmeuropa Online for information and posted on the EDQM website as part of the resolution.

Revision of the European Pharmacopoeia

Monographs and other texts of the European Pharmacopoeia are revised as necessary following a decision of the Commission. Revision proposals are published in Pharmeuropa Online. Proposals to revise monographs may be submitted by a delegation, by the Chair of the Commission or by the chair of a group of experts. Requests for revision from other parties should be submitted via the national pharmacopoeia authority of a member state or, where this is not possible, to the EDQM via the HelpDesk. Proposals to revise monographs must be accompanied by sufficient data to justify the need for revision.