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 GUIDELINE ICH 三方协调指南 THE COMMON TECHNICAL DOCUMENT FOR THE REGISTRATION 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 2 MODULE 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 guideline is recommended for ado
