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 genera