Q1a[R2]-2003-新原料药及新制剂稳定性设计研究[中英文].doc

WORD整理版 优质参考资料 INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH Harmonised Tripartite Guideline Stability Testing of New Drug Substances and Products Q1A(R2) Current Step 4 version dated 6 February 2003 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. ICH指导原则 新药物与新产品稳定性研究Q1A（R2） 2003.2.6现行第4版 Q1A(R2) Document History First Codification History Date New CodificationNovember 2005 Q1 Approval by the Steering Committee under Step 2 and release for public consultation. 16 September 1992 Q1 Q1A Approval by the Steering Committee under Step 4 and recommendation for adoption to the three ICH regulatory bodies. Q1 was renamed Q1A. 27 October 1993 Q1A Q1A(R) Approval by the Steering Committee of the first revision under Step 2 and release for public consultation. 7 October 1999 Q1A(R1) Q1A(R) Approval by the Steering Committee of the first revision under Step 4 and recommendation for adoption to the three ICH regulatory bodies. 8 November 2000 Q1A(R1) Current Step 4 version Q1A(R2) Approval by the Steering Committee of the second revision directly under Step 4 without further public consultation, to include consequences of the adoption of Q1F (Stability Data Package for Registration Applications in Climatic Zones III and IV), and recommendation for adoption to the three ICH regulatory bodies. 6 February 2003 Q1A(R2) Cover Note for Revision of Q1A(R) Stability Testing of New Drug Substances and Products 新药物与新产品稳定性研究Q1A（R）修正说明 The purpose of this note is to outline the changes made in Q1A(R) that result from adoption of ICH Q1F “Stability Data Package for Registration Applications in Cli