欧洲药典元素杂质实施策略

2015-05-02  

   

28 April 2015, Strasbourg, France

2015年4月28日，法国，斯坦伯格

Ph.Eur. POLICYON ELEMENTAL IMPURITIES

欧洲药典，元素杂质原则

Background. In preparation for implementation of the ICH Q3Dguideline on elemental impurities, the European Pharmacopoeia (Ph. Eur.)Commission endorsed a preliminary implementation strategy at its 149thSession(June 2014) and information on this strategy was communicated in a pressrelease issued on 18 July 2014.

背景：在准备实施IHC Q3D元素杂质指南的过程中，欧洲药典委员会在其149次会议上（2014年6月）采用了一个初步的实施策略，该策略的信息已在2014年7月18日的媒体上公布交流。

The ICH Q3D guideline on elemental impurities was finallysigned-off at the end of 2014 and it was published on the ICH website on 16December 2014. In the following weeks, the Committee for Medicinal Products forHuman use (CHMP) set implementation dates of June 2016 for new marketingauthorisation applications and of December 2017 for all existing products onthe EU market.

ICH Q3D元素杂质指南在2014年底最终签字生效，2014年12月16日在ICH网站上公布。在之后几周内，人药委员会CHMP设定了实施日期为：新上市许可申报2016年6月，所有已在欧盟上市的药品2017年12月。

The Ph. Eur. Commission then went on to approve a refinedstrategy for the different texts impacted by the ICH Q3D guideline at its 151st session(March 2015):

欧洲药典委员在151次会议（2015年3月）上对受到ICH Q3D影响的不同内容继续批准了更详细的策略如下：

Heavy metalstest (chapter 2.4.8). The process ofdeleting the Heavy metals test from individual Ph. Eur. monographs is currentlyongoing. A list of the monographs concerned was published for publicconsultation in Pharmeuropa 27.2 (deadline for comments: 30 June 2015). Giventhe large number of monographs requiring revision, the final date for deletionof this test from all monographs on substances for pharmaceutical use (exceptmonographs for veterinary use only) will be aligned with the publication of the9th edition of the Ph. Eur. (i.e. implementation date of 1 January 2017).It should be noted that the absence of the heavy metals test from an individualmonograph does not preclude substance manufacturers from controlling the levelsof elemental impurities in their products. Control of heavy metals according tomethod 2.4.8 is still acceptable until ICH Q3D comes into force for a givenfinished product.

重金属测试（第2.4.8章）。从EP各论中删除重金属的正在进行的过程中。受影响的各论已 27.2（征求意见截止日期2015年6月30日）中公布。由于所需修订的各论较多，该测试从所有药用物质各论中删除的最终日期（除兽药专用各论外）统为一在EP第9版公布（即生效时间为2017年1月1日）。要注意的在各论中没有了重金属项目并不是说物质的生产商不要控制在其产品中控制元素杂质水平。在ICH Q3D对指定的制剂生效前，采用2.4.8控制重金属的方法仍然是可以接受的。

Individual metaltests. The Ph. Eur. individual metal tests forindividual synonym class 1, 2A, 2B and 3 elemental impurities (according to theICH Q3D guideline) will be assessed individually by the responsible Group ofExperts. The Ph. Eur. Commission has recommended that, unless otherwisejustified, these tests be deleted from monographs once the ICH Q3D guidelinecomes into force. Conversely, the Ph. Eur. Commission also recommended keepingthe different tests for elements with no established Permitted Daily Exposure(PDE) limits, i.e. those identified as “other elements” in the ICH Q3Dguideline (e.g. Al and Fe), in individual monographs. Any changes will be madein alignment with the date the ICH Q3D guideline becomes applicable for allproducts on the market (December 2017).

单个重金属。EP中1类、2A类、2B类和3类元素杂质（根据ICH Q3D指南）单个重金属测试将由相关的负责专家组进行单个评估。除另有论述外，EP委员会建议一旦ICH Q3D指南生效，即将这些测试从各论中删除。相反，EP委员会还建议在各论中对于没有建立PDE限度的元素保持不同的检测，即，那些在ICH Q3D指南（例如，铝和铁）中被认为“其它元素”的元素杂质。所有已上市药品均应在ICH Q3D指南生效日期进行变更（2017年12月）。

Chapter 5.20. The“Metal catalyst or metal reagent residues” chapter,which is currently a verbatim reproduction of the EMA Guideline on thespecification limits for residues of metal catalysts or metal reagents , willbe replaced by a verbatim copy of the ICH Q3D guideline. This will be done intime for the implementation date applicable for existing products on the EUmarket (December 2017) and the revised chapter will be published in Supplement9.3 of the Ph. Eur. (implementation date 1 January 2018).

第5.20章。“金属催化剂或金属试剂残留”章节，现在是从EMA金属催化剂或金属试剂残留限度的指南逐字复制的，将会由ICH Q3D指南的原版复制内容所替代。这个会在欧盟已上市的药品实施日期（2017年12月）时完成，修订后的章节会在EP的9.3版本中公布（实施日期2018年1月1日）。

Additionally, in Supplement 9.3, the Ph. Eur. intends tointroduce a cross-reference to revised chapter 5.20. in the general monographPharmaceutical preparations (2619) thus making application of the ICH Q3Dguideline mandatory for all the medicinal products the latter covers. Therevised monograph Pharmaceutical preparations (2619) will be published inPharmeuropa for public enquiry in due time.

另外，在9.3增补版中，EP将会引入对修订章节5.20的交叉索引，在通论药品制剂（2619）中使ICH Q3D指南成为所有该通论适用的药品必须满足的条件。修订后的各论药品制剂（2619）将在欧洲药典在线公布以征求公众意见。

Chapter 2.4.20. Currently entitled “Determination of metal catalyst andmetal reagent residues“, this chapter provides additional guidance for aspectsof method development such as sample preparation and method validation. At itsmeeting in June 2014, the Pharmacopoeial Discussion Group (PDG) decided toharmonise their respective general chapters on elemental impurities.Harmonisation of chapter 2.4.20 is currently being discussed and the Ph. Eur.Commission may need to revise chapter 2.4.20 to align its title and contentwith the ICH guideline Q3D, if the harmonised PDG chapter has not yet beenpublished.

第2.4.20章。现在题为“金属催化剂和金属试剂残留检测”的章节为方法开发方面提供了额外的指南，例如样品制备和方法验证。在2014年6月的会议中，第2.4.20章节的药典讨论组PDG决定将其与相应的元素杂质通论保持一致。第2.4.20章的一致性现在正在讨论中，EP委员会可能会需要修订第2.4.20章，以保持其题目和内容与ICH Q3D指南一致，假如一致的PDG章节还没有公布的话。

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

联系人：欧洲委员会，EDQM，公关部，Caroline LarsenLe Tarnec

Note for theEditor: Furtherinformation is available on the internet site www.edqm.eu

编者注：更多信息参见上述网站。

The EDQM is a leading organisation that protects publichealth by enabling development, supporting implementation, and monitoring theapplication of quality standards for safe medicines and their safe use. Ourstandards are recognised as a scientific benchmark world-wide. The EuropeanPharmacopeia is legally-binding in European Member States. Similarly, the EDQMdevelops guidance and standards in the areas of blood transfusion, organtransplantation and consumer health issues.

1There are now thirty-eight members of the European Pharmacopoeia Commission:Austria, Belgium, Bosnia and Herzegovina, Bulgaria, Croatia, Cyprus, the CzechRepublic, 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, UnitedKingdom 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 RussianFederation, Senegal, South Africa, Syria, Tunisia, United States of America,the Taiwan Food and Drug Administration (TFDA) and the World HealthOrganization (WHO).

欧洲药典委员会现有38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、丹麦、爱沙尼亚共和国、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、马耳它、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、前南斯拉夫的马其顿共和国、土耳其、乌克兰、英国和欧盟。有27个观察国：阿尔巴尼亚、阿尔及利亚、阿根廷、阿美尼亚、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、摩洛哥、白俄罗斯、几内亚、哈萨克斯坦、新加坡、俄罗斯、塞内加尔、南美、叙利亚、突尼斯、美国、台湾和世卫组织WHO。

A politicalorganisation set up in 1949, the Council of Europe works to promote democracyand human rights continent-wide. It also develops common responses to social,cultural and legal challenges in its 47 member states.

来源：http://zhuyujiao1972.blog.163.com/blog/static/98694727201542104322413/

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