EMEA指导原则.pdf

The European Agency for the Evaluation of Medicinal Products Evaluation of Medicines for Human Use London, 25 July 2002 CPMP/SWP/2877/00 COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) NOTE FOR GUIDANCE ON CARCINOGENIC POTENTIAL DISCUSSION IN THE SAFETY WORKING PARTY January – November 2000 TRANSMISSION TO THE CPMP January 2001 RELEASE FOR CONSULTATION January 2001 DEADLINE FOR COMMENTS April 2001 RE-DISCUSSION IN THE SWP February - June 2002 ADOPTION BY CPMP July 2002 DATE FOR COMING INTO OPERATION January 2003 Note: This Note for Guidance (3BS7a), first adopted in 1983, has been updated to refer to the ICH- guidelines on carcinogenicity testing (S1A, CPMP/ICH/140/95; S1B, CPMP/ICH/299/95; S1C, CPMP/ICH/383/95 and S1CR, CPMP/ICH/366/96) and other relevant ICH guidelines. 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 8613 E-mail: mail@ EMEA 2002 Reproduction and/or distribution of t