New GMP Guidance for MarketingAuthorisation Holders

MAH的GMP指南

After longdiscussions, the European Medicines Agency EMA has published a Reflection Paperon Good Manufacturing Practice and Marketing Authorisation Holders (EMA/457570/2019).

经过长时间的讨论，欧盟药监局（EMA）发布了一份关于GMP和MAH的反思文件。

The documentfocusses on good manufacturing practice (GMP) responsibilities applicable toMarketing Authorization Holders (MAH). Business models have been changing overthe years and many companies hold the MA, but contract many or all GMP relatedactivities out. For some of them it is not easy to understand all theirresponsibilities for the product, which can, "in some cases, bedifficult to comprehend when reading the GMP guide or the applicablelegislation". "Responsibilities are spread overthe various chapters and annexes of the GMP guide, and are quite numerous",EMA points out in the introduction. And Annex 16 to the EU-GMP guidelinesstates that the "ultimate responsibility for the performance of amedicinal product over its lifetime, its safety, quality and efficacy, lieswith the marketing authorisation holder (MAH)." Although certainactivities may be delegated to a contract acceptor, the "MAH retainsthe responsibilities which are outlined in this paper".

该文件重点阐述了适用于上市许可持有人(MAH)的GMP责任。商业模式多年来一直在变化，许多公司持有MA，但许多或所有的GMP相关活动都外包给合同组织。对于他们中的一些人来说，不容易理解他们对产品的所有责任，这些责任“在某些情况下，在阅读GMP指南或适用的法律时很难理解”。欧盟药品监督管理局在导言中指出:“责任分散在GMP指南的各个章节和附件中，而且相当多。”。欧盟GMP指南附录16规定，“药品在其生命周期内的性能、安全性、质量和功效的最终责任在于上市许可持有人(MAH)。”虽然某些活动可以委托给第三方方，但”MAH仍负有本文件概述的职责”。

How this Reflection Paper sets out thevarious MAH responsibilities

本反思文件如何规定MAH的各项责任

In section 5 ofthe paper, each GMP requirement that applies to the MAH is outlined, with itskey message stated or summarised. These are:

在文件的第5节中，概述了适用于MAH的每个GMP要求，并对其关键信息进行了说明或总结。包括:

• Outsourcing and technical agreements;

• 外包和技术协议;

• Audits and qualification activities;

• 审计和确认活动;

• Communication with manufacturing sites (e.g. MA dossier information, variations, regulatory commitments, etc.);

• 与生产工厂沟通(例如MA档案信息、变更、法规承诺等);

• Product Quality Reviews;

• 产品质量回顾;

• Quality defects, complaints and product recalls;

• 质量缺陷、投诉和产品召回;

• Maintenance of supply of medicinal products;

• 维持药品供应;

• Continual improvement activities.

• 持续改进活动。

In addition tothose, Chapter 6 discusses FMD-related responsibilities for MAHs, includingresponsibilities for safety features, repositories systems, serialisation datauploading and unique identifier decommissioning.

除此之外，第6章还讨论了MAHs与FMD（药品防伪指令）相关的职责，包括安全特性、存储系统、序列化数据上传和唯一标识符退役的职责。

GDP-relatedresponsibilities that may apply to MAHs are not directly addressed in thepaper. Nevertheless, "MAHs do need to understand the type of interfacesthat may need to be in place with the wholesalers they employ or engage."

本文件没有直接述及可能适用于MAHs的与GDP（良好分销规范）有关的责任。尽管如此，“MAHs需要了解他们所雇用或使用的批发商可能需要的接口类型。”

文件翻译中，近期发出来！