ICHQ中英文分析和总结.pdf

INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ARMONISED RIPARTITE UIDELINE ICH H T G OOD ANUFACTURINGRACTICE UIDE FOR CTIVE HARMACEUTICALNGREDIENTS G M P G A P I Q7 Current Step 4 version dated 10 November 2000 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 final draft is recommended for adoption to the regulatory bodies of the European Union, Japan and USA. 中英文对照 Q7 Document History First History Date New Codification Codification November 2005 Q7A Approval by the Steering Committee under Step 2 19 July Q7 and release for public consultation. 2000 Current Step 4 version Q7A Approval by the Steering Committee under Step 4 and recommendation 10 November 2000 Q7 for adoption to the three ICH regulatory bodies. OOD ANUFACTURINGRACTICE UIDE FOR CTIVE HARMACEUTICALNGREDIENTS G M P G A