| 文件名称： | ICH HARMONISED GUIDELINE EVALUATION AND RECOMMENDATION OF PHARMACOPOEIAL TEXTS FOR USE IN THE ICH REGIONS Q4B(R1) |
| 发布机构： | International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use(ICH) | 发布日期： | 2024-06-05 |
| 简介/内容概述： | This document describes the process for the evaluation and recommendation of selected pharmacopoeial texts to facilitate their recognition by regulatory authorities for use as interchangeable by the ICH regulatory members. This process was initially under the responsibility of the ICH Q4B Expert Working Group (EWG) until it was disbanded at the end of 2010. The Pharmacopoeial Discussion Group (PDG) took over this responsibility in November 2018. |
