EMEA基因毒性杂质限度指南课题.docVIP

20060628 EMEA/CHMP/QWP/251344/2006 基因毒性杂质限度指南（中英文对照） London, 28 June 2006 CPMP/SWP/5199/02 EMEA/CHMP/QWP/251344/2006 The European Agency for the Evaluation of Medicinal Products 欧洲共同体药物评审委员会 (EMEA) COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE 人用药品委员会 (CHMP) GUIDLINE ON THE LIMITS OF GENOTOXIC IMPURITIES 基因毒性杂质限度指南 DESCUSSION IN THE SAFETY WORKING PARTY 安全工作组之内的讨论 June 2002-October 2002 TRANSMISSION TO CPMP CPMP传递 December 2002 RELEASE FOR CONSULTATION 专家讨论 December 2002 DEADLINE FOR COMMENTS 建议收集最后期限 March 2003 DISCUSSION IN THE SAFETY WORKING PARTY AND QUALITY WORKING PARTY 安全工作组和质量工作组之间的讨论 June 2003-February 2004 TRANSMISSION TO CPMP 转移给CPMP March 2004 RE-RELEASE FOR CONSULTATION 再次放行给顾问团 June 2004 DEADLINE FOR COMMENTS 收集意见的最后期限 December 2004 DISCUSSION IN THE SAFETY WORKING PARTY AND QUALITY WORKING PARTY 安全工作组和质量工作组之间的讨论 February 2005-May 2006 ADOPTION BY CHMP 被CHMP采用 28 June 2006 DATE FOR COMING INTO EFFECT 生效日期 01January 2007 KEYWORDS 关键词 Impurities; Genotoxicity; Threshold of toxicological concern (TTC); Structure activity relationship (SAR) GUIDLINE ON THE LIMITS OF GENOTOXIC IMPURITIES 基因毒性杂质限度指南 TABLE OF CONTENTS 目录 EXECUTIVE SUMMARY 内容摘要.............................................................................................. 3 1. INTRODUCTION 介绍............................................................................................................... 3 2. SCOPE 范围 ............................................................................................................................... 3 3. LEGAL BASIS法 律依据............................................................................................................ 3 4. TOXICOLOGICAL BACKGROUND 毒理学背景.................................................................... 4 5. RECOMMENDATIONS 建议..................................................................................................... 4 5.1 Genotoxic Compounds With Sufficient Evidence for a Threshold-Related Mechanism 具有充分证据证明其阈