翻译 ：JULIA 来源： Julia法规翻译
21.06.2017
Elemental Impurities - Binding Risk Assessment forAuthorised Medicinal Products
元素杂质—已上市药品关联风险评估
The provisions laid down in the ICH Guideline Q3D"Elemental Impurities" for new authorisations of medicinal products havebeen applying since June 2016. Already authorised and marketed products have tocomply with those requirements as of December 2017.
在ICH Q3D指南“元素杂质”中的规定自2016年6月开始适用于新的上市申报。原有批准和上市药品则必须自2017年12月起符合这些要求。
Beside the document "Implementationstrategy of ICH Q3D guideline" (see also "EMA's new Guideline on the Implementationof the ICH Q3D Guideline in the EU"), the EMA's website also offers anotherdocument which was already published in February 2015 and is intended toprovide support for medicinal product manufacturers when applying ICH Q3D toexisting marketed products: "Elemental impurities in marketed products.Recommendations for implementation" - EMA/CHMP/QWP/109127/2015. One of thecentral statements of the document is that medicinal product manufacturersshall perform in any case a risk assessment for existing productsalready during the transition period and - if necessary - hold it ready in caseof an authority inspection.
除了文件“ICH Q3D指南实施策略”（也参见“EMA的ICH Q3D指南在EU实施新指南”），EMA官网也于2015年2月提供了另一份文件，意在为药企申请已上市药品的ICH Q3D提供支持：“已上市药品中的元素杂质：实施建议”-- EMA/CHMP/QWP/109127/2015。EMA文件声明中有一点是要求药品生产商在过渡期间就对现有所有药品均进行风险评估---必要时---在药监检查期间应能提供。
Moreover, clarification is provided regardingquestions about the necessity to submit a variation application to theregulatory authority. According to the outcome of the risk assessment, novariation procedure is required when:
还有，文件中也澄清了关于是否需要向药监机构提交变更申报的问题。根据风险评估的结果，在以下情况时不需要执行变更程序：
There is no need for a control on elemental impurities to materials for the API (starting material), the API and its intermediates and the excipients.
对物料的元素杂质没必要进行控制，如原料药（起始物料）、原料药和其中间体以及辅料
No change is required in the production equipment or in the source of supply of the starting materials, APIs and excipients,
对生产设备没有必要进行变更，对起始物料、原料药和辅料供应来源没必要进行变更
No change is needed in the manufacturing process.
对生产工艺没有必要进行变更
When one or more of these conditions doesn't apply, avariation application has to be submitted. The variation should also contain ashort summary of the risk assessment and its conclusions.
如果上述一个或多个条件不符合，则必须提交变更申报。变更中应包括风险的摘要及所做出的结论。
In the event that a control strategy is required forone or several elemental impurities, an elemental specific analytical methodhas to be used. A non-specific compendial procedure for heavy metals won't beaccepted.
如果需要对一个或几个元素杂质采取控制策略，则必须使用具有专属性的分析方法，药监不接受非专属性的药典重金属方法。
