INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE
人用药注册技术要求国际协调会议
ICH Harmonised Tripartite Guideline
人用药注册技术要求国际协调会议三方协调后的指南
Quality Risk Management
质量风险管理
Current Step 4 version
现行第四步版本
dated 9 November 2005
2005
年十一月
9日This Guideline has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. At Step 4 of the Process the fin ...