GMP和MAH思考文

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14 January 2020

EMA/457570/2019

GMP/GDP Inspectors Working Group

 

Reflection paper on Good Manufacturing Practice and Marketing Authorisation Holders

GMP和MAH思考文

 

Draft  agreed by GMP/GDP Inspectors Working Group	June  2019
GMP/GDP检查员工作组通过草案	2019年6月
Adopted  by GMP/GDP Inspectors Working Group for release for consultation	June  2019
GMP/GDP检查员工作组采纳发布征求公众意见	2019年6月
Start of  public consultation	17  January 2020
开始征求公众意见	2020年1月17日
End of  consultation (deadline for comments)	17 April  2020
征求意见结束	2020年4月17日

 

Comments should be providedusing this template. The completed comments form should be sent to  adm-gmdp@ema.europa.eu

应采用模板提交意见。填写完成的意见表应发至adm-gmdp@ema.europa.eu

Keywords	Good  Manufacturing Practice, GMP, Marketing Authorisation Holder, MAH
关键词	优良生产规范，GMP，上市许可持有人，MAH

1. Introduction and purpose概述与目的

This Reflection Paper is focused on the GMP-related responsibilities that apply to Marketing Authorisation Holder (MAH) companies. While it is recognised that many MAH companies are not directly engaged in the manufacture of medicinal products themselves, the current European Commission (EC) guide to GMP (hereafter referred to as the ‘GMP guide’) refers, in several places, to MAHs and their responsibilities in relation to GMP.

本思考文着重关注上市许可持有人（MAH）公司与GMP相关的义务。虽然许多MAH公司自己并不直接从事药品生产业务，但当前EC GMP指南（以下称为GMP指南）在多个地方仍写入了MAH及其与GMP有关的义务。

In general, these responsibilities relate to outsourcing and technical agreements, that require the MAH to perform certain specific tasks (e.g. evaluating the results of product quality reviews, agreeing irradiation cycles with manufacturers, etc.).These responsibilities are spread over the various chapters and annexes of the GMP guide, and are quite numerous.

一般来说，这些义务与外包和技术协议相关，需要MAH执行特定的具体任务（例如评估药品质量审核结果、与生产商协定辐射周期等）。这些义务散布在GMP指南的不同章节和附录中，数量众多。

This Reflection Paper seeks to provide clarity as to what the various responsibilities are and what they mean for MAHs at a practical level. In addition to the MAH responsibilities in the GMP guide, this paper also addresses the various legislative provisions (i.e. in European Directives and in other guidelines) which relate to GMP and which concern MAHs. Some of the responsibilities stated in the legislation (e.g. in Directives 2001/83/EC and 2001/82/EC) and in applicable guidelines are written in a way that they apply to marketing authorisation applicants, and they are included in this Reflection Paper because those provisions also convey responsibilities upon marketing authorisation holders in the post-authorisation phase.

本思考文意在厘清MAH有哪些义务，从实践角度来说对MAH具有什么意义。除了MAH的GMP义务外，本报告亦阐述不同的法律条款（即欧洲指令和其它指南中的内容）中与GMP和MAH有关的内容。在法律（例如指令2001/83/EC 和2001/82/EC）和适用指南中所称的一些义务称其适用于上市许可申报人，在本报告中亦有包括，因为这些条款在批准后亦会转移成为MAH的义务。

It should be noted that, as indicated in Annex 16 of the GMP guide, the ultimate responsibility for the performance of a medicinal product over its lifetime, its safety, quality andefficacy, lies with the MAH. It is also important to note that, while certain activities of an MAH may be delegated to a manufacturer or other party, the MAH retains the responsibilities which are outlined in this paper. The GMP guide  also does not provide for reduced MAH responsibilities (or for the delegation of responsibilities) in situations where the MAH and the manufacturer belong to the same overall group of companies but where the two companies are different legal entities. There is no difference in the responsibilities that apply to the MAH in this situation relative to when the MAH and the manufacturer are from separate and unrelated companies.

要注意的是，正如GMP指南附录16所称，一个药品在其生命周期的性能、质量和有效性的义务是属于MAH的。还有一点也很重要，虽然MAH可以将特定的活动委托给一个生产商或其它方，但该MAH仍负有本报告中所列出的义务。即使MAH与生产商属于相同集团但为相互独立的实体，GMP指南亦未减少MAH的义务（或责任分派）。在此情形下适用于MAH的义务相较于MAH与生产商为相互独立完全不相干的公司的情形并无不同。

While relevant activities pertaining to the GMP-related responsibilities held by MAHs may be delegated by the MAH to its representative (if there is one) in a member state, none of the responsibilities may be delegated to that person. (Note: The representative of the MAH, commonly known as the local representative, is the person designated by the MAH to represent him in the Member State concerned. (Ref. Part 18a of Article 1 in Directive 2001/83/EC and Part 17a of Article 1 of Directive 2001/82/EC).

虽然MAH可以将其GMP相关职责范围内的相关活动指派给其在一个成员国的代表（如有），但并不能由该人员承担任何责任（注：MAH的代表，一般指本地代表，是MAH指派在相关成员国内代表该MAH的人员）。（参见指令2001/83/EC第1款第18a节，和指令2001/82/EC第1款第17a节）

It is recognised that, while MAHs have a significant role in facilitating GMP and MA compliance, their responsibilities in this area can, in some cases, be difficult to comprehend when reading the GMP guide or the applicable legislation. Notwithstanding this, such responsibilities are there and may be inferred. This Reflection Paper seeks to provide clarity on these.

众所周知，虽然MAH在促进GMP合规和符合MA中有着重要作用，但对照GMP指南和适用法律时会发现，有时候MAH在此方面的职责可能是难以全面履行的。

All of the references currently in the GMP guide (as of April 2019) that relate to MAH responsibilities are discussed in this Reflection Paper. This paper, however, should not be taken to provide an exhaustive list of those references on an ongoing basis. Rather, it sets out the general GMP-related responsibilities and activities of the MAH, and it presents them under a number of different themes.These themes are outlined below in Section 5. MAH companies should have a system in place to ensure that they remain up-to-date with current GMP requirements and updates thereafter.

本思考文中讨论了GMP指南中与MAH义务有关的所有引用内容（截止2019年4月）。虽然如此，随着时间发展，本报告不应作为这些引用条款的完整清单，其中只是列出了一般的GMP相关职责和MAH活动，代表了大量不同主题下的内容。这些主题列在本报告第5部分中。MAH公司应具备一个体系确保其与现行GMP要求及更新内容保持同步。

Where possible, the text within each theme provides an explanation of what the various responsibilities may mean at a practical level for MAHs; guidance is also given on what is expected of an MAH when fulfilling that responsibility. It should be noted, however, that this Reflection Paper does not provide guidance on ‘how’ the various responsibilities might be fulfilled.

每个主题中的内容尽可能解释了不同职责对MAH在实践层面的含义，亦给出了在履行其职责时对MAH的要求。应注意的是尽管如此，但本思考文并不提供“如何”履行各种职责的指南。

Article 111 of Directive 2001/83/EC and Article 80 Directive 2001/82/EC give powers to member state authorities to inspect the premises of MAH companies; this includes situations in which there are grounds for suspecting non-compliance with the legal requirements laid down in the Directives, including with the principles and guidelines of GMP. When such inspections are carried out, this Reflection Paper may serve as useful guidance for the competent authorities performing the inspections.

指令2001/83/EC第111款和指令2001/82/EC第80款赋予成员国药监机构检查MAH公司设施的权力，其中包括基于疑似不符合这些指令中法定条款（包括GMP原则和指南）所执行的检查。在执行此类检查时，本思考文可作为药监当局执行检查的有用指南。

       文章来源：蒲公英

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