欧洲药典的更新

©2012 EDQM, Council of Europe, All rights reserved
12
112
Ph. Eur. Commission
• One delegation per member state or observer • 36 member states plus a delegation from the EU (representatives from DG Health & Consumers and the EMA); 24 Observer countries and World Health Organization (WHO). • Delegates come from health ministries, health authorities, pharmacopoeias, universities, or industry and are appointed by the national authorities on the basis of their expertise. • Three sessions a year; texts are adopted by unanimous vote. • Currently 20 permanent Groups of Experts & 52 ad hoc Working Parties - > 250 meeting days/ year for experts; Composition of groups of experts decided by Ph. Eur. Commission • One Secretariat: EDQM/Ph. Eur. Department (EPD)
• Protecting public health - one common compulsory standard • The Ph. Eur. is the official pharmacopoeia in Europe – complemented by national pharmacopoeias for texts of interest to only one Member State • Mandatory at the same date in 36 Member States (CoE) and the EU (decision of Ph. Eur. Commission). • Legally binding quality standards for ALL medicinal products in its member states, i.e. raw material, preparations, dosage forms, containers must comply with the Ph. Eur. requirements when they exist.
©2012 EDQM, Council of Europe, All rights reserved
工作通则
• 基于由欧洲药典委员会（药典管理主体）指定的不同 专家组和工作组成员之间的科学合作，药典专论或其 它文本的起草和批准经过了一个高效、透明和顺利运 作的过程。
©2012 EDQM, Council of Europe, All rights reserved
©2012 EDQM, Council of Europe, All rights reserved
©2012 EDQM, Council of Europe, All rights reserved
14
113
The European Pharmacopoeia: More than 2187 Monographs
©2012 EDQM, Council of Europe, All rights reserved
– protection of human rights – pluralist democracy & the rule of law
©2012 EDQM, Council of Europe, All rights reserved
5
欧洲理事会
– 建于1949年 – 欧洲共同和民主原则的发 展 – 47个成员国 – 总部位于斯特拉斯堡 – 核心价值：
©2012 EDQM, Council of Europe, All rights reserved 13
欧洲药典委员会
• 每个成员国或观察员一名代表 • 36个成员国以及一名欧盟代表（卫生与消费者总局和EMA代表)； 24个观察国和WHO。. • 卫生部、卫生部门、药典、大学或企业代表，由国家主管当局根 据其专业水平任命。 • 每年三次会议：内容经过不记名投票决定采纳。 • 现在20个永久性专家组&52个特设工作组：每年超过250天专家会 议；由药典委员会决定专家组成员 • 一个秘书处：EDQM/Ph. Eur. Department (EPD)
©2012 EDQM, Council of Europe, All rights reserved
工作通则(2)
• 专家们贡献出时间、专业和经验来建立公众可获得的 最高水平的质量标准，这些质量标准随着科技发展进 行持续改进。 • 来自于法规部门、官方药品控制实验室、学院和企业 等的专家的合作，代表了科学合作的最高峰，以得到 高质量的技术专论和章节。
2
107
Agenda
• • • • • • • • The EDQM and the Ph. Eur. General working principles Control of wenku.baidu.commpurities Heavy metals P4 procedure: a success story Ph. Eur. and “Quality by Design” Ph. Eur. strategy in the biological field Ph. Eur. and adulterants
©2012 EDQM, Council of Europe, All rights reserved
11
欧洲药典
• 保护公共健康：一种普遍的义务标准 • 欧洲药典是欧洲的正式官方药典–以各成员国的国家药典作为补 充，该国家药典内容仅对该国有用 • 在36个成员国（欧洲委员会）和欧盟内同一天强制生效（欧洲 药典委员会决策）. • 对欧盟成员国内所有药品标准具有法定约束力，如原辅料，制 剂，剂型，容器必须符合欧洲药典现存标准的规定。
110
European Regulatory Network
©2012 EDQM, Council of Europe, All rights reserved
欧洲立法网络
©2012 EDQM, Council of Europe, All rights reserved
111
European Pharmacopoeia (Ph. Eur.)
108
The Council of Europe
– Founded in 1949 – Development of European common and democratic principles – 47 member countries – Headquarters in Strasbourg – Core values :
116
General Working Principles (2)
• Experts give of their time, expertise and experience to produce the highest-level quality standards available to the public, standards that are continually revised in line with scientific developments. • This co-operation between experts from regulatory authorities, OMCLs, academia, and industry represents the pinnacle of scientific co-operation to produce a high standard of technical monographs and chapters.
欧洲药典：超过2187个专论
©2012 EDQM, Council of Europe, All rights reserved
114
GENERAL WORKING PRINCIPLES
©2012 EDQM, Council of Europe, All rights reserved
17
工作通则
©2012 EDQM, Council of Europe, All rights reserved 18
115
General Working Principles
• Elaboration and approval of monographs and other texts proceeds through an efficient and transparent, smooth-running process, based on scientific cooperation between the members of the various Groups of Experts and Working Parties assigned by the European Pharmacopoeia Commission, the governing body of the Pharmacopoeia.
– 人权保护 – 多元化民主&法制
©2012 EDQM, Council of Europe, All rights reserved
6
109
European Directorate for the Quality of Medicines & HealthCare (EDQM)
• A Council of Europe Directorate, based on the Convention on the Elaboration of a European Pharmacopoeia (PA, 1964) • Mission: to contribute to a basic human right: access to good quality medicines and healthcare
©2012 EDQM, Council of Europe, All rights reserved
欧洲药品质量管理局（EDQM)
• 欧 洲 指 导 委 员 会 ， 基 于 发 展 欧 洲 药 典 的 共 识 (PA, 1964) • 使命：为基本人权做贡献：良好 药品和卫生保健质量
©2012 EDQM, Council of Europe, All rights reserved
Update on the European Pharmacopoeia
Dr. Susanne Keitel Workshop on GMP/Pharmacopoeia/API Beijing, 11-12 July 2012
1
欧洲药典的更新
Susanne Keitel博士 GMP/药典/API研讨会 北京, 11-12 July 2012
©2012 EDQM, Council of Europe, All rights reserved 3
日程
• • • • • • • • EDQM及欧洲药典 工作通则 杂质控制 重金属 P4规程：一个成功的故事 欧洲药典和“质量源于设计” 生物领域内的欧洲药典策略 欧洲药典和掺杂物
©2012 EDQM, Council of Europe, All rights reserved 4