( )...... GMP...... 3...........................
................................. 2001...
2001... 2002...........................
......... 863..............................
...........................
.....................
( )
2001-1-4 5 150
GMP GMP GMP 14 GMP --- GMP GMP GMP
GMP GMP 10 GMP 5 GMP GMP --- 9 --- GMP
GMP GMP GMP 3 2000-12-4 1124, 3
2000-11-2 [2000]207
2001-2-15 2001 17
331 2000-12-5 [2000]160 [2000]229
[2000]147 147 12 GMP -- 6219721 2001-2-16
[1999]242 20012 7 19993 ( )
() ( ) () 1 2 3 4 5 6 7 8
1 2 3 4 5 6 () 2001225 610 A4 1 2 3
4 5 6 ( ) 7 8 2000 () 2001225610 () 200135630
() 200141730
2004 20016
0898-5333118 5332540 1. 2. 2000-11-30 92 1000 20 1000
6000 50 30 4 PPA 2 2001-2-28 2001-4-1
2001220 68
1999
200141 2000-12-11 ( ) 10
2001-2-28 2001-4-1 2001220 68
4%
1 30
200141 B1 B2 B E(5mg)
B4 B6 B12 C D2 D3 ( ) ( )( ) (1) ( ) (2) (3) (4)
(17) (18F) (3H) (1) (2) (3) (4) 2000-12-15
83,43.4%
[2000]42 2001 2005
00 2000-12-11
1. ( ),,7 ( ) GMP, GMP2.
3 3. (2001
220 68 ) 12 1. 2. 3. 4. 5. 6. 7.
8. 9. 10. 11. 12.
K1 ( ) ( II VI IX X) (1) (2) (3) ( ) ( ) K3 K4 ( )
( ) () ( ) ( )
( ) 70 ( )( )
( ) / ( ) ( ) ( ) () ( )
2000-12-14 1130 13 66. 2001 2001-4-26 2001 36
2001 [2001]12 2001 1 2 3
4 5 1 2 3 4 1 20
2 15 2001 () 10139 00 11 30 ( ) 14 00 16 30 ( ) ()
10149 00 11 30 14 00 16 30 ( )
( ) [ ] 2000, 2000 200165-69
3 / 6 65687030 65688039 38 62091715 11 64287072 3
www.bjpta.gov.cn www.bjda.gov.cn 2001 2001-4-19 2001 6
3 2 3+2 5 www.sda.gov.cn; www.bjp.gov.cn
zhou.g.y@bjda.gov.cn 2002 2002-4-10 2002-4-24 [2002]35 2002
[2002]14 [2001]49 2002
1012 9:00-11:30 2:00-4:30 1013 9:00-11:30 2:00-4:30
1 20 2 15 1 1988 10
2 1990 8 3 199941 2002424 428 8:30-16:30 11 6
65688039 11 64286989 38 62091715 418
www.bjpta.gov.cn 2001 2001
2002 16898100 (www.bjpta.gov.cn) 2000-12-20
1 2 1 2 3 100 100 30
2001-3-19 [2001]19
2001220 68 1978 104 ( )
y 200141 200141 2001331 25 20
2001331 60%
35 4570 3545 70 1% 2% 4.8% 4.3%
200141 1998630 20019987 1 100
1300650 50% 5 90 90
180 270 90 180 90 50% 1231
11
,
1988 550 1988 550
200141 2001319 2000
2001-2-28 2001 18 (2001 220 68 )
2001228 2000 2001-2-28 2001 17
(2001 220 68 )
2001228 2000 2001-2-28 [2001]26
2001 220 68
2001228 2500 2001-2-28 [2001] 13
?? 2001220 68
2001228 2000 2001-2-28 2001 16
2001 220 68 4%
2001228 2000 [2001]211
10 30 IP IP
30
30 30
30
20
[2001]211
10 30
IP IP 30
30 30
30
20
2001-2-20 [2000]562
1 2
3 4 5 6 3 2000 334
200171 20046 30 2004630 2001 200149 13
7409 200162 2001630 863 2000-12-1 863 20 20
863 50 K-001
5 5 5 19961212
6503.5048 5 10
2000-11-27 WTO
2001-1-5 42
() () () 2 2 () () ()
2001 2001 ( ) 2001 200211 2001 2001 200211 2001-2-28 2001-4-1
2001220 68
1% 3
2000 50% 50% 1500 70 60% 40% 70 70% 30% 2 70% 30% 10
120 30 120
200141 (5%,10%,25%,50%)
( ) ( ) 1. ( ) (1) (2) (3)
( )( ) 2. 3. ( )( )( ) ( )
a-
( ) ( )()
( ) ( ) ( )( ) ( ) ( )
a- D ( ) 1 2
)
1 2 200mg 20ml 2
1. (1) (2) (3) (4)
2 (1) (2) (3) (4) 3 (1) (2) (3) (4) (5) 4 (1) (2) (3) (4) 5 (1) (2) (3) (4)
(5) 6 (1) a b c d e (2) a b 7 (1) (2) (3) (4) (5) (6)
2001-5-24
10 30
IP IP 30
30 30
30
20
2001-2-28 2001-4-1 2001220 68 4
, () 1
200141