20171128 ECA新闻：ATMP的GMP---EC采用新指南

28.11.2017

GMP for ATMP - European Commission adopts newGuideline

ATMP的GMP---EC采用新指南

With the first publication of a draft guideline on GMP for ATMPin 2016, we havebeen reporting several times about the two rounds of publicconsultations. You could also read about the subsequent developed document and stakeholdercomments aswell as about the following discussionwith the PIC/s on the content of the document and on the suitability of such a standalone document instead of an additional annex to the European GMP Guideline.

在2016年首次发布ATMP的GMP指南草案后，我们已报道过几次其两次公开征求公众意见。你也可以看看其后写就的文件，以及干系的建议，和之后与PIC/S之间关于文件内容和此单独文件替代EU GMP指南附录的讨论。

Now, on 22 November, the European Commissionhas adopted the 'New Guidelines on Good Manufacturing Practice specific to AdvancedTherapy Medicinal Products'. As date for coming in operation the new documentdefines: 'ATMP manufacturers should comply with these Guidelines nolater than 22 May 2018'.

现在，11月22日，EC已经采纳了“ATMP专用GMP新指南”。新文件的生效日期开始，ATMP生产商应最迟自2018年5月22日起符合这些指南。

At the beginning of the first chapter of theguideline, the 'scope', the authors state that GMP is required forall medicinal products with a marketing authorisation and  an equivalentquality standards for products made under hospital exemption. Additionally theypoint out that the development of such specified guidelines for ATMP aremandated by Article 5 of Regulation (EC) No 1394/20072 as well as by Article 63(1) of Regulation (EU) No 536/2014 for IMPD.

在指南的第一章开头“范围”中，作者声明了所有上市许可中的药品均应符合GMP，医院豁免情况下生产的药品应具备等同的质量标准。此外，他们指出ATMP特定指南是依据法规1394/20072第5条以及法规536/2014第63（1）IMPD条款所制订的。，

The new guideline includes requirements forATMP with a marketing authorisation as well as for advanced therapymedicinal products that are being tested or used as reference in a clinicaltrial (i.e. advanced therapy investigational medicinalproducts).The document should be the main document for the definitionof the GMP requirements for ATMP, so in the scope it states:' These Guidelines do not apply to medicinal products other thanATMPs. In turn, the detailed guidelines referred to in the second paragraph ofArticle 47 of Directive 2001/83/EC4 and Article 63(1) of Regulation (EU) No536/2014 do not apply to ATMPs, unless specific reference thereto is made inthese.' 

新指南包括了对具备上市许可的ATMP的要求，以及测试或用作临床试验参照药品的ATMP（即，ATMP临床试验药品）。文件是ATMP的GMP要求定义的主要文件，因此在范围中其称“这些指南并不适用于非ATMP药品。反过来，在指令2001/83/EC第47条第二段以及法规536/2014第63（1）中的详细指南并不适用于ATMP，在其中有具体引用者除外”。

A look on the length of over 80 pages and on thetable of content shows that the status as a stand alone guideline has madeit necessary to include all important fields with relation to ATMPs whichare normally covered for other medicinal products in the existing GMPguideline and its Annexes:

看一下长达80多页的篇幅，以及目录就知道它作为一份独立指南的身份，因而在其中有必要包括了所有与ATMP有关的重要领域，而这些在当前其它产品GMP指南及附录中一般已包括了：

• Risk based approach 基本风险的方法

• Personal 人员

• Premises 设施

• Equipment 设备

• Documentation 文件记录

• Starting/Raw Materials 起始物料/原料

• Seed lot and call bank systems 种子批和细胞库系统

• Production 生产

• Qualification and Validation 确认和验证

• QP and batch release QP和批放行

• Quality Control 质量控制

• Quality defects and recalls 质量缺陷和召回

• Reconstitution 重新调配

• Automated production 自动化生产

In several bullet points of these chapters topics likehygiene aspects up to aseptic processing requirements andfinally batch release issues are covered. For the manufacturers of ATMP,it will now be the challenge to check whether the current established processeswill be in accordance with the new guideline or whether some changes oradditional activities will be necessary. 

在这些章节中的几个要点中的主题包括了如卫生方面至无菌工艺要求以及最终的批次放行问题。对于ATMP的生产商，现在将成为一个挑战，要检查是否当前建立的流程是依据新指南还是需要有一些变更或额外的措施。

Being aware of these challenges the ECA Academywill organise a workshop on 'GMP for ATMPs' in Berlin, Germanyon 21 (and possibly 22) June 2018. The detailed programme will be publishedsoon.

知晓这些挑战的存在，ECA将于2018年6月21日（可能在22日）组织在柏林召开“ATMP的GMP”培训。详细的计划将很快发布。