- 1
1 3 2 5 3 6 4 7 5 9 6 13 7 14 8 15 9 16 10 FDA 20 11 23 12 24-2
TOP 1 3 22 GDP 20 10 2003 1980 2000 43 188 8 4.1 50 2004 32 1 3-3
Cipla 350 1 3 2001 11 Trade Related Aspects of Intellectual Property Rights Trips 400 1000 3 22 3-4
UNAIDS : TOP 2 1995 WTO 49 2016 HIV HIV WTO 7 2500 123-5
TOP 3 2000 HBV 30 15 20 HbsAg 59 9 1 Hb sag 1994 300 1998 12-6
2002 FDA 120 2003 10 DNA 21 HBV HBV DNA TOP 4 2005 1 1-7
CADN INN IUPAC R TM 4-8
TOP 5 4 2 10 53 10 2000 3 30 12 2004 7 5 2004 (SFDA) - 9
2004 SFDA 90 SFDA SFDA 20 70 10 5-10
C 100 C 11 SFDA SFDA SFDA SFDA SFDA - 11
SFDA 11 2004 44246 1782 96 (http://www.bioon.com) - 12
TOP 6 2006 1 1 GMP 2005 GMP - 13
TOP 7 10 14 2002 2004 1 3 4500 650 1 16 20-14
200 TOP 8 3 17 FDA( ) (LesterCrawford) FDA FDA FDA 9 Vioxx( ) 11 FDA (DavidGraham) Vioxx 14 FDA - 15
Vioxx Vioxx FDA 2 18 3 Celebrex( ) Bextra( ) Vioxx FDA FDA Vioxx -2(COX-2) 1999 Vioxx FDA -2-2 FDA - 16
FDA FDA FDA FDA FDA 32 10 10 FDA 2 Prozac( ) Paxil( ) FDA FDA 1990 FDA FDA FDA ( FDA - 17
TOP 9 3 30 12 4 12 9 4 1 10 2 9 12 3 6228 6228 6228 2004 7 5 26 3-18
ED 6228 26 3 2001 10 18 2001 9 19 6228 12 6 12 16 17 6 7-19
2002 9 3 2001 11 TOP 10 FDA FDA 94 (Chinese CEO Organization) 12 12 60 FDA - 20
( ) 2001 "9 11" 305 ( ) FDA FDA FDA 60 40 " " " " FDA FDA FDA " " - 21
FDA " " " " " " " " " FDA " ( )" " " FDA FDA - 22
TOP 11 59-23
TOP 12 3 ( ) - 24
2000 2004 3 31 54 122 49 2 7 1 8 16 5 5 2 4 ( ) ( ) 2000 No.98803744.0 No.00137059.6 ( ) 13-25
? ( ) 2002 11 8 (5mg10mg)( ) I II - 26
2002 3 13 1374314 2002 1 0 16 2002 7 8 1396170 2003 2 12-27