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ICH Q4B ICH区域内使用的药典正文的评估和建议 常见问题

20120426 （中英文）

2013-05-28 11:13:08| 分类： ICH guideline | 标签： |举报 |字号大中小 订阅

Frequently Asked Questions

常见问题

Q4B: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions

Q4B：ICH区域内使用的药典正文的评估和建议

The Q4B Expert Working Group developed a set of frequently asked questions to help users of the Q4B

Guideline and Annexes to understand the use and implication of these documents.

Q4B专家工作组针对一些常见问题进行解答，以帮助Q4B指南及附录的使用者理解这些文件的使用方法和含义

Document Date: 26 April 2012 文件日期：2012年4月26日

International Conference on Harmonisation of Technical Requirements for

Registration of Pharmaceuticals for Human Use ICH Secretariat, Chemin Louis-Dunant 15, P.O.Box 195, 1211 Geneva 20,

Switzerland

Telephone: +41(22)338 32 06, Telefax: +41 (22) 338 32 30

admin@ich.org, http://www.ich.org

Table of Content

目录

1. what is PDG? 什么是PDG？ 2. what is Q4B? 什么是Q4B？

3. why is Q4B necessary? 为什么需要Q4B？

4. how does industry use the Q4B Annexes? 企业如何使用Q4B附件？ 5. how do regulators use the Q4B Annexes? 药监人员如何使用Q4B附件？

6. When can Q4B Annexes be used? Q4B附件何时开始使用？

7. can harmonized pharmacopoeial text be considered interchangeable in counties/regions outside of ICH? 已经统

一的药典内容在ICH以外的国家/地区是否可认为是可互换的？

1. What is PDG? 什么是PDG？

The Pharmacopoeial Discussion Group (PDG) was formed in 1989 with representatives from the European Directorate for the Quality of Medicines

(EDQM)/European Pharmacopoeia (Ph. Eur.), United States Pharmacopoeia (USP), and Japanese Pharmacopoeia (JP) to work on harmonising excipient monographs and general chapters in the pharmacopoeias. In 2001, the PDG welcomed the World Health Organization (WHO) as an observer. While not part of ICH, the PDG typically met in conjunction with the ICH and provides the ICH Steering Committee with reports of its harmonisation progress.

药典讨论组（PDG）组成于1989年，成员为EDQM/欧洲药典（EP）代表、美国药典（USP）代表、日本药典(JP)代表。其工作内容为统一药典中辅料各论和通论。在2001年，PDG欢迎WHO作为观察员。由于PDG并不是ICH的一部分，PDG一般是与ICH举办会议，向ICH委员会提供统一进度的报告。

The PDG considers proposals made by national and regional associations of

manufacturers of pharmaceutical products and excipients in order to select general methods of analysis and excipient monographs for addition to its harmonisation work programme. To promote these exchanges and synergy, since 2001, the PDG has organised, upon request, hearings for representatives of the pharmaceutical and excipient industries. At all times, PDG works to maintain an optimal level of science consistent with protection of the public health.

PDG听取了各国和地区药品和辅料企业联合会的提议，以便选择通用分析方法和辅料各论，将其加入统一工作议程。为促进这种交流和协作，在要求下，PDG组织了由制药企业和辅料生产企业代表参加的听证会。PDG工作组在所有时间均保持为保护公众安全而要求的最高的科学一致性。

Each pharmacopoeia is responsible for a programme of international harmonisation. Each text drafted by the three co-ordinating pharmacopoeias is published for public comment at PDG Stage 4 in each of their respective forums. Please refer to the Working Procedures of the PDG, for further information. See the pertinent pharmacopoeial website.

每部药典都是对国际统一项目负责。由三方协调药典起草的正文均在PDG第4阶段在各自相应的论坛上公开征求意见。请参见PDG的《工作程序》获取更多信息。参见有关的药典官网。

2. What is Q4B? 什么是Q4B？

Q4B is an ICH Expert Working Group (EWG) established in November 2003. As with all of the ICH EWGs, it is composed of regulators and industry representatives of the three ICH regions, with some observers. The subject of Q4B is \Recommendation of Pharmacopoeial Texts for Use in the ICH Regions\evaluated by Q4B are primarily the result of harmonisation by the Pharmacopoeial Discussion Group (PDG). The aim of Q4B is to recommend that the texts published in the three pharmacopoeias (Ph. Eur., JP and USP) can be used as interchangeable. Texts determined to be interchangeable, can be used by industry and accepted by the regulators of the three regions. The recommendation of interchangeability is provided in a series of topic-specific “Annexes” as published on the ICH website (www.ich.org). Q4B是ICH专家工作组（EWG）于2003年11月建立的指南。与ICH其它专家工作组一样，它由ICH三方的企业代表和药监人员，以及一些观察者组成。Q4B的主题是“ICH区域内使用的药典正文的评估和建议”。由Q4B评估过的正文内容作为PDG的初步统一结果。Q4B的目标是建议三部药典（EP JP和USP）中公布的内容可以等效互换。确认为可以互换的正文内容，可以由企业使用，由三方药监部门接受。可互换建议以系列专题附件形式公布在ICH官网上。

The initial scope, as approved by the ICH Steering Committee, was composed of the 10 general chapters mentioned in the ICH Guideline Q6A on specifications,

subsequently expanded with 5 additional chapters. The scope does not include any excipient, drug substance, or drug product monographs.

初始项目由ICH委员会批准，由ICH的Q6A质量标准指南中提到的10个通用章节组成，随后扩大到5个附加章节。其范围不包括任何辅料、原料药或药品各论。 The overall process of Pharmacopoeial Harmonisation (Q4A: PDG) associated with the process for evaluation of interchangeability (Q4B EWG) defines the current framework of ICH Q4.

药典协调(Q4A: PDG)的总体进度与互换性评估(Q4B EWG) 界定了现行ICH的Q4框架。

3. Why is Q4B necessary? 为什么需要Q4B？

One of the ultimate goals for the pharmaceutical industry is the ability to generate analytical data by a single test method which is acceptable in each region. This goal of interchangeable test methods has not been achieved, and companies have been