EMEA基因毒性杂质限度指南.docxVIP

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 Europea n Age ncy for the Evaluatio n of Medici nal 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 June 2002-October 2002 PARTY 安全工作组之内的讨论 TRANSMISSION TO CPMP December 2002 CPMP传递 RELEASE FOR CONSULTATION December 2002 专家讨论 DEADLINE FOR COMMENTS March 2003 建议收集最后期限 DISCUSSION IN THE SAFETY WORKING June 2003-February 2004  PARTY AND QUALITY