【技术交流】欧洲药典委员会宣布其元素杂质实施策略及将来ICH Q3D指南的实施计划

【技术交流】欧洲药典委员会宣布其元素杂质实施策略及将来ICH Q3D指南的实施计划2014-08-14 Julia 蒲公英杂志

THE EUROPEAN PHARMACOPOEIA COMMISSION VALIDATES ITS STRATEGY REGARDING ELEMENTAL IMPURITIES AND THE IMPLEMENTATION PLAN OF THE UPCOMING ICH Q3D GUIDELINE
欧洲药典委员会宣布其元素杂质实施策略及将来ICH Q3D指南的实施计划
   Following its last meeting in early June 2014, the ICH Steering Committee announced the plan to move their Guideline for elemental impurities (ICH Q3D), to Stage 4 in September 2014. As the sign off of this new tripartite guideline approaches, a strategy for the revision of the Ph. Eur. texts concerned has been drawn up by the European Pharmacopoeia Commission to ensure that a consistent approach between the licensing
authorities and the Ph. Eur. continues to be applied.
在2014年6月最后一次ICH筹委会会议中，ICH宣布将在2014年9月推出Q3D的第4阶段终稿。在新指南草稿确定后，欧洲药典委员会制订了对欧洲药典相关正文的修订策略，以保证核发上市许可的一致性，并使欧洲药典能持续适用。
Currently, the EMA Guideline on the specification limits for residues of metal catalysts or metal reagents (EMEA/CHMP/SWP/4446/2000), which is reproduced verbatim in chapter 5.20 “Metal catalyst or metal reagent residues” of the Ph. Eur., is applicable to new drug products to be marketed in Europe.
目前，EMA关于金属催化剂或金属试剂残留标准指南（EMEA/CHMP/SWP/4446/2000）已全文成为欧洲药典的5.20章“金属催化剂和金属试剂残留”，适用于在欧洲上市的新药。
In its June session, the European Pharmacopoeia Commission endorsed the proposed revision strategy of the current “Heavy metals chapters” and decided as a first step to revise chapter 5.20, to replace its content by the ICH Q3D guideline as soon as it has moved to Stage 5 in the European Union. Indeed, the decision to replace the EMA guideline on the specification limits for residues of metal catalysts or metal reagents by the ICH Q3D guideline is under the remit of the Committee for Medicinal Products for Human Use (CHMP).
在其6月的会议中，欧洲药典委员会批准了对现行版“重金属章节”的修订策略，决定将其作为对5.20章修订的第一步，一旦ICH Q3D指南在欧盟进入第5阶段，则采用该指南取代该章节。实际上，采用ICH Q3D指南取代EMA的金属催化剂和金属试剂残留标准指南是CHMP提出的。
In this regard, it should be noted that the reproduction of a Guideline in a Ph. Eur. Chapter does not make it legally binding as long as the Chapter is not referenced in a Ph. Eur. monograph. In line with a previous decision taken in April 2012, the Ph. Eur. intends to introduce a cross-reference to this revised chapter in the general monographs Substances for pharmaceutical use (2034) and Pharmaceutical preparations (2619) at a later stage, making the requirements of the ICH Q3D Guideline legally binding. The exact timing of this step will depend on the implementation decisions of other European regulation bodies, mainly the CHMP.
关于此，需要注意的是尽管欧洲药典照搬了指南内容，但只要在欧洲药典各论中没有引用，则该章节并非强制。为与2012年4月的决定保持一致，欧洲药典决定在迟些阶段对通论2034“药用物质”和2619“药品制剂”进行修订，并做一个交叉引用，使得ICH Q3D指南的要求成为强制性法规。这一步的具体实施时间将取决于其它欧洲法规部门的实施决定，主要是CHMP的决定。
In addition, it is planned to delete cross-references to the wet chemical tests for “heavy metals” described in chapter 2.4.8 from all individual monographs (except for monographs on products for veterinary use only). The list of all impacted monographs will be published in Pharmeuropa, in January 2015 (issue 27.1). It is currently foreseen to publish the revised individual monographs in the 9th edition with an implementation date of 1 January 2017.
另外，会议还决定删除所有各论（除仅兽用药品的各论外）中对第2.4.8章“重金属”化学方法检测的交叉引用。受影响各论的清单将在2015年1月（27.1）欧洲药品杂志中公布。目前预期修订后的各论将在EP9中公布，在2017年1月1日实施。
From then on, the choice of an appropriate analytical strategy will be left to the user, in line with the ICH Q3D guideline. Chapter 2.4.20, currently entitled “Determination of metal catalyst and metal reagent residues”, which focuses on sample preparation and method suitability, will provide additional guidance. Together with other general chapters related to elemental impurities analysis, it will be thoroughly reviewed to align them, if necessary, with the latest requirements and possibilities given by the ICH Q3D guideline.
此后，用户将负责选择适当的分析策略，使其符合ICH Q3D的要求。第2.4.20章，目前题为“金属催化剂和金属试剂残留的检测”，主要内容是样品制备和方法适用性，将给用户提供更多的指南。与其它和元素杂质分析的章节一起，我们会对该章节进行彻底的审核，并在必要时修订，以使其保持与ICH Q3D指南的最终要求和可能性保持一致。
Additionally, the Pharmacopoeial Discussion Group (PDG) decided at its last meeting in June 2014 to start the discussions on the harmonisation of their respective chapters on elemental impurities. More information on the work programme of the PDG can be found in the corresponding press release.
另外，药典讨论组（PDG）在2014年6月的最后一次会议中决定启动元素杂质相关章节的一致性讨论。关于PDG的更多工作项目信息，可以在相关的新闻发布资料上找到。
Contact: Caroline Larsen Le Tarnec, Public Relations Division, EDQM, Council of Europe

Tel.: +33 (0) 3 88 41 28 15 - E-mail: caroline.letarnec@edqm.eu

Note for the Editor: Further information is available on the internet site www.edqm.eu
It has the objective of progressively elaborating a common European Pharmacopoeia, which defines a single set of specifications for active substances and excipients used in medicines that will become the official standards applicable within these countries. The European Pharmacopoeia also describes test methods to ensure the quality of these medicines. The EDQM is a leading organisation that protects public health by enabling development, supporting implementation, and monitoring the application of quality standards for safe medicines and their safe use. Our standards are recognised as a scientific benchmark world-wide. The European Pharmacopeia is legally-binding in European Member States. Similarly, the EDQM develops guidance and standards in the areas of blood transfusion, organ transplantation and consumer health issues.
There are now thirty-eight members of the European Pharmacopoeia Commission: Austria, Belgium, Bosnia and Herzegovina, Bulgaria, Croatia, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Montenegro, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, the former Yugoslav Republic of Macedonia, Turkey, Ukraine, United Kingdom and the European Union. There are twenty-seven observers: Albania, Algeria, Argentina, Armenia, Australia, Azerbaijan, Brazil, Canada, China, Georgia, Israel, Madagascar, Malaysia, Moldova, Morocco, Republic of Belarus, Republic of Guinea, Republic of Kazakhstan, Republic of Singapore, the Russian Federation, Senegal, South Africa, Syria, Tunisia, United States of America, the Taiwan Food and Drug Administration (TFDA) and the World Health Organization (WHO).
目前欧洲药典委员会有38个成员（国）：奥地利、比利时、波斯尼和黑塞哥维纳（波黑）、保加利亚、科斯达黎加、塞浦路斯、捷克、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、马尔他、黑山、荷兰、挪威、波兰、葡萄牙、罗马尼亚、塞尔维亚、斯洛伐克、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、英国和欧盟。有27个观察员：阿尔巴尼亚、阿尔及亚、阿根廷、亚美尼亚、澳大利亚、阿塞拜疆、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、摩那哥、白俄罗斯、几内亚、哈萨克斯坦、新加坡、俄罗斯联邦、塞内加尔、南非、叙利亚、突尼斯、美国、台湾食品药品管理局（TFDA）和世界卫生组织（WHO）。
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新闻网址：http://www.edqm.eu/en/The-Europe ... -1587.html?mbID=218
原文版权归属原作者，译文仅供参考。
18 July 2014, Strasbourg, France
法国，施特拉斯伯格，2014年7月18日

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