精选优质文档-倾情为你奉上INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE人用药物注册技术要求国际协调会议ICH Harmonised Tripartite GuidelineICH 三方协调指南The Common Technical Document for theRegistration of Pharmaceuticals for Human Use:人用药物注册通用技术文件Quality质量Quality Overall Summary of Module 2Module 3 : Quality模块2:质量概要模块3:质量Having reached Step 4 of the ICH Process at the ICH Steering Committee meeting on 9 November 2000, this