GMP News

12/10/2016

What are the GMP Responsibilities of the Marketing Authorisation Holders?

上市许可持有人的GMP职责有哪些？

The GMP/GDP Inspectors Working Group of the European Medicines Agency (EMA) has published a concept paper to summarise the GMP responsibilities of the Marketing Authorisation Holders (MAH). It is not intended to introduce any new responsibilities on MAHs but to document existing requirements in a better way.

EMA的GMP/GDP检查工作组发布了一份概念文件，总结了上市许可持有人(MAH)的GMP职责。其意并不是引入任何新的MAH职责，而是以一种更好的方式来展现现有要求。

The current EU GMP-Guidelines define in several chapters and annexes GMP tasks and responsibilities of the MAH. However, there seems to be a lack of clarity and understanding as to what these responsibilities actually are in their totality, and what they mean for MAHs at a practical level. All these tasks and responsibilities have now been summarised in this concept paper:

目前EU GMP指南中已在几个章节和附录中定义了MAH的GMP任务和职责。但是，看起来还是缺乏对于这些职责总体是些什么，以及在实际操作层面这些对MAH来说又意味着什么的澄清和理解。所有这些任务和职责现在在此概念文中进行了汇总。 

Chapter 1: responsibility to evaluate the results of the PQR review

第1章：负责评估PQR审核的结果 

Chapter 7: responsibility to put contracts in place

第7章：负责保证合同制订 

Chapter 8: responsibilities concerning quality defects, risk-reducing actions and notification of possible disruption in supply

第8章：关于质量缺陷、风险降低的措施和通知供应中可能的损害的职责

Annex 2: responsibility to put contracts in place

附录2：负责保证合同制订 

Annex 12: obligations to approve the design of irradiation cycles, and agreeing the location for retention of irradiation cycle records.

附录12：有义务批准放射周期设计，同意放射周期记录保存位置

Annex 16: requirement to identify the site and QP responsible for certifying each batch (in the case of multiple sites authorised to manufacture / imp

ort / certify the same product) and the statement that the "ultimate responsibility for the performance of a medicinal product over its lifetime, its safety, quality and efficacy" lies with the MAH

附录16：MAH所要求的识别工厂和QP认证每个批次（如果有多个工厂被批准生产/进口/认证相同产品）和声明“在药品生命周期内对其安全性、质量和有效性表现负有无限责任”

Annex 19: responsibilities for ensuring that reference and retention samples are taken, and stored.

附录19：负责确保对照品和留样取样以及存贮

The GMP/GDP Inspectors Working Group thinks that the issues outlined above "are not without important consequences. The way in which MAHs are expected to interact with the manufacturing sites registered in a marketing authorisation is not sufficiently clear, given the diverse ways in which the various MAH responsibilities are set out in the EC Guide to GMP, and differing (often complex) supply chains."

GMP/GDP检查工作组认为上列问题“并不是没有重要后果的。MAH与上市许可中注册的生产工厂互动的方式不够清楚，在EC的GMP指南中设定的不同MAH职责有多种方式，与供应链（通常比较复杂）情况有差异”。 

So what is next? 接下来呢？ 

According to the Concept Paper, "It is recommended that the GMP/GDP Inspectors Working Group (GMP/GDP IWG) should produce a reflection paper intended for Part III of the EU GMP Guide or in another appropriate location (e.g. as proposed by the GMP/GDP IWG). This would capture all of the responsibilities that apply to MAH companies to enable manufacturers to comply with GMP. It would also result in a more complete picture of the regulatory environment with respect to GMP in which the MAH operates."

根据概念文，“建议GMP/GDP检查工作组（GMP/GDP IWG）应为EU GMP指南第III部分和其它地方（例如，GMP/GDP IWG提议的）的要求制订反思文”。 

The deadline for comments on the concept paper is end of November 2016. Comments should be sent to adm-gmdp@ema.europa.eu.

概念文的征求建议最后期限为2016年11月底。建议应提交至上述邮箱。