The ICH Q14 Guideline reached Step 4 of the ICH process on 1 November 2023. The Q14 EWG developed a new ICH Quality Guideline, ICH Q14, on Analytical Procedure Development.

2023年11月1日 · ICH指导原则由国家药品监督管理局药品审评中心发布，提供药品研发和审评的指导。

This document describes a process for the evaluation and recommendation by the Q4B Expert Working Group of selected pharmacopoeial texts to facilitate their recognition by regulatory authorities for use as interchangeable in the ICH regions.

经 Q4B 专家工作组（EWG）审核，ICH 指导委员会建议，欧洲药典附录 2.9.17（注射剂 装量检查法）、日本药典附录 6.05（注射剂装量检查法）以及美国药典附录<1>注射剂制剂通 则“装量”中各自规定的分析方法，在 ICH 区域中具有同等效力。

In November 2003, ICH had established the Q4B EWG to evaluate and recommend pharmacopoeial texts to be proposed for interchangeable use in the three founding ICH regions (USA, European Union, Japan).

In November 2003, ICH established the Q4B EWG to evaluate and recommend pharmacopoeial texts that are proposed for use in the three ICH regions. The Q4B EWG anticipates that the PDG will be the principal source of pharmacopoeial text proposals.

This annex is the result of the Q4B process for Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests. The proposed texts were submitted by the Pharmacopoeial Discussion Group. It aims to facilitate the recognition of pharmacopoeial procedures for microbial enumeration tests by regulatory authorities in the ICH regions.

2020年12月10日 · 蒲友们：ICH指导原则详解第四弹来了，今天早一点，昨天太忙临近下班了才想起。 废话不多，走起来。 老规矩，留下专业小红心，下一秒它就是你的了， ...,ICH指南指导原则详解-第四弹（Q4系列）,蒲公英 - 制药技术的传播者 GMP理论的实践者

2017年9月27日 · The ICH Q4 guidelines are generally seen as one of the least successful of the ICH quality initiatives. ICH Q4 is split into Q4A (Pharmacopoeial Harmonization) and Q4B (Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions).

中国医药工业杂志 ›› 2019, Vol. 50 ›› Issue (03) : 349-354. DOI: 10.16522/j.cnki.cjph.2019.03.017. 本文简要介绍了国际人用药品注册技术协调会 ( ICH...