20150730 ECA新闻：制剂生产EMA新指南

20150730 ECA新闻：制剂生产EMA新指南

2015-07-30 19:51:39

GMP News
30/07/2015

New EMA Guideline on the Manufacture of the finished Dosage Form

制剂生产EMA新指南

Although the title draft Guideline on Manufacture of the finished Dosage Form might indicate that the content of this new guideline relates to manufacturing of investigational medicinal products and/ or marketed products, it does not introduce new GMP requirements. The guideline applies to the description of the manufacturing method in the application, namely in the CTD Module 3 of the marketing authorisation dossier. This guideline should be read in conjunction with Directive 2001/83/EC Article 8.3 (d) (ref 2) where it is stated that the application for a marketing authorisation shall contain a description of the manufacturing method. The requirements on the description of the manufacturing method are described in Annex 1of the directive and are further elaborated in this new guideline.

尽管草案的标题“制剂生产指南”看起来貌似该新指南的内容与临床前药品和/或上市药品生产有关，但它实际介绍的新的GMP要求。该指南适用于申报的生产方法描述，即上 市许可文档CTD模块3。该指南应与指令2001/83/EC第8.3(d)(ref 2)款一起解读。在上述条款中，要求上市许可的申报资料应包括关于生产方法的描述。关于生产方法的描述要求在指令的附录1中有描述，现在整合进了这个新的指南中。

The guideline replaces the Note for Guidance on the Manufacture of the finished Dosage Form (CPMP/QWP/486/95) with the aim to:

该指南替代了制剂生产指南注意事项(CPMP/QWP/486/95) ，其目的是：

• reflect changes to the format and content of the Common Technical Document (CTD) Module 3 dossier
• 反映CTD模块3文档的内容和格式变化
• address current manufacturing practices in terms of complex supply chains and worldwide manufacture
• 说明复杂供应链和全球生产环境下现行生产规范
• take into account principles of the ICH Q8 guideline
• 考虑了ICH Q8指南的原则
  

and - as a result - provide clarification on the type and level of information that should be included in the CTD Module 3 of the marketing authorisation application (MAA) dossier with respect to the manufacturing process description. The headings of the guideline follow the structure of the CTD format Module 3, Section 3.2.P.3 Manufacture. Only product specific aspects of manufacture need to be described and included in the MA-dossier; general elements of Good Manufacturing Practice (GMP) should not be included.

因此，还提供了在上市许可申报（MAA）CTD模块3中应包括的生产工艺描述资料类型和水平的说明。指南的标题与CTD格式模块3第3.2.P.3生产一致。只有生产中产品特定方面需要包括进行描述并在MA文档中，GMP的常规要素则不需要包括。