EMA关于生物研发用药的质量文件要求

EMA - requirements for quality documentation concerning biological investigational medicinal products

EMA关于生物研发用药的质量文件要求

Already in 2012, the European Commission published a guideline on the quality documentation for IMP in clinical trials. Now on 23 June, the EMA issued a draft "Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials". It is open for public consultation from 1 July until 31 December 2016. The new draft should be read in connection with Regulation (EU) No. 536/2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC, which came into force on June 20, 2014.

在2012年，EC已经公布了临床用IMP质量文件指南。今年6月23日，EMA发布了“关于生物临床研发用药质量文件要求指南”。自7月1日开始征求意见，截止2016年12月31日。新草案应与EU NO.536/2014“人药临床试验”以及2014年6月20日生效的申诉指令2001/20/EC一起解读。

The EMA summarizes the scope of the document as follows:

EMA总结文件范围如下：

"This guideline addresses the specific documentation requirements on the biological, chemical and pharmaceutical quality of IMPs containing biological / biotechnology derived substances. Moreover, this guideline lists, as regards documentation on the biological, chemical and pharmaceutical quality of the IMP, examples of modifications which are typically considered as 'substantial'. The guidance outlined in this document applies to proteins and polypeptides, their derivatives, and products of which they are components (e.g. conjugates). These proteins and polypeptides are produced from recombinant or non-recombinant cell-culture expression systems and can be highly purified and characterised using an appropriate set of analytical procedures. The guideline also applies to Auxiliary Medicinal Products containing these proteins and polypeptides as active substances.

“本指南说明了含有生物/生物技术衍生物质的IMP的生物、化学和药学质量的特定文件要求。另外，关于IMP的生物、化学和药学质量方面，本指南列出了一般认为是“真实的”修订。在此文件中列出的指南适用于蛋白质和多肽、其衍生物以及以其作为成分（例如，偶合物）的药品。这些蛋白质和多肽是由重组或非重组细胞培养表达系统产生的，可以高度纯化，使用适当的分析方法系列进行确证。指南还适用于包含蛋白质和多肽作为活性物质的辅助药品。”

The principles may also apply to other product types such as proteins and polypeptides isolated from tissues and body fluids. Advanced Therapy Medicinal Products are excluded from this guideline."

“这些原则也适用于其它类型的药品，如从组织和体液分离出来的蛋白质和多肽。创新治疗药品不在本指南范围中。”

Related to the fact that the most available guidance documents for biological products address the quality requirements for marketing authorisation applications and are often not really applicable for a clinical trial application, this document outlines principles which should be taken into consideration during product development. But the guidelines on Virus safety evaluation of biotechnological investigational medicinal products (EMEA/CHMP/BWP/398498/05) and Strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicinal products (EMEA/CHMP/SWP/28367/07) should be read in conjunction.

由于最易获得的说明上市许可申报质量要求的生物药品指南文件常常并不真的适用于临床试验，因此在药品研发中应考虑本文件中列出的原则，但应该与上述2指南结合解读。

More details and the information for submitting comments can be found directly in the Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials.

提交建议的更多信息参见上述链接。