()
... 1... 6... 7... 10... 13... 14... 20... 22... 24 I
... 27... 29 2001... 29 2001... 36 2002... 38... 45... 53... 67... 69 II
... 71... 73... 75... 78 ( )... 93... 109 863... 113 ()... 114... 122... 123... 124 III
... 125 5... 125 55.65... 126... 127... 128... 131... 132 1... 136... 138... 139... 140... 142... 144 IV
... 146... 148... 149... 152... 154... 156... 158... 159... 162... 162... 165... 168... 170... 170 V
2000... 173... 175... 175... 180... 180... 182... 183... 186... 190... 191 VI
2001-2-28 2001-4-1 2001220 68 1
2
3
1999 4
5
200141 2000-12-11 ( ) 10 6
2001-2-28 2001-4-1 2001220 68 7
4% 8
1 30 200141 9
B1 B2 B E(5mg) B4 10
B6 B12 C D2 D3 ( )( ) ( )( ) (1) ( ) (2) (3) (4) 11
(17) (18F) (3H) (1) (2) (3) (4) ( ) 12
2000-12-15 83,43.4% 13
[2000]42 2001 2005 14
15
16
17
18
19
2000-12-11 20
1. ( ),,7 ( ) GMP, GMP 2. 3 21
3. (2001 220 68 ) 12 1. 22
2. 3. 4. 5. 6. 7. 8. 9. 10. 23
11. 12. 24
K1 ( ) ( II VI IX X) (1) (2) (3) ( ) ( ) K3 K4 ( ) 25
( ) () ( ) ( ) 26
( ) 70 ( )( ) 27
( ) / ( ) () ( ) ( ) () 28
( ) 2000-12-14 1130 13 66. 2001 2001-4-26 29
2001 36 2001 [2001]12 2001 1 2 30
3 4 5 1 2 3 4 31
1 20 2 15 2001 () 10139 00 11 30 ( ) 14 00 16 30 ( ) () 32
10 149 00 11 30 14 00 16 30 ( ) ( ) 33
[ ] 2000,, 2000 200165-69 3 34
35 / 6 65687030 65688039 38 62091715 11 64287072 3 www.bjpta.gov.cn
www.bjda.gov.cn 2001 2001-4-19 2001 6 36
3 2 3+2 5 www.sda.gov.cn; www.bjp.gov.cn zhou.g.y@bjda.gov.cn 37
2002 2002-4-10 2002-4-24 [2002]35 2002 38
[2002]14 [2001]49 2002 39
1012 9:00-11:30 2:00-4:30 1013 9:00-11:30 2:00-4:30 40
1 20 2 15 1 1988 10 41
2 1990 8 3 199941 2002424 428 8:30-16:30 11 6 65688039 42
11 64286989 38 62091715 418 www.bjpta.gov.cn 43
2001 2001 44
2002 16898100 (www.bjpta.gov.cn) 2000-12-20 45
46
47
48
1 2 1 2 3 100 100 49
30 50
51
52
2001-3-19 [2001]19 53
2001220 68 1978 104 ( ) 54
55
y 200141 200141 2001331 56
25 20 57
2001331 60% 58
35 4570 3545 70 1% 2% 4.8% 4.3% 59
200141 1998630 20019987 1 100 60
1300650 50% 5 90 61
90 180 270 90 180 90 50% 62
1231 11 63
, 64
1988 550 1988 550 65
200141 2001319 66
2000 2001-2-28 2001 18 (2001 220 68 ) 67
2001228 2000 68
2001-2-28 2001 17 (2001 220 68 ) 69
2001228 2000 70
2001-2-28 [2001]26 2001 220 68 71
2001228 2500 72
2001-2-28 [2001] 13?? 2001 220 68 73
2001228 2000 74
2001-2-28 2001 16 2001 220 68 75
4% 76
77
2001228 2000 [2001]211 78
79
80
10 81
30 IP IP 30 82
83
84
85
86 30
30 87
88
89
30 90
91
92
20 ( ) 93
94 [2001]211
95
96
10 30 IP IP 97
30 98
99
100
101
30 30 102
103
104
105
30 106
107
20 108
2001-2-20 [2000]562 109
1 2 3 110
4 5 6 3 2000 334 111
200171 20046 30 2004630 2001 200149 13 112
7409 200162 2001630 863 2000-12-1 863 20 20 113
863 50 K-001 () 2000-12-28 () 1 ( Amoxicillin ) 2 ( Ampicillin Sodium 114
) 3 ( Oxacillin Sodium ) 4 ( Cloxacillin Sodium ) 5 [Benzylpenicillin[Sodium,Potassium] ] 6 V Phenoxymethylpenicillin Potassium 7 Cefalexin 8 Cefradine 9 Cefotaxine Sodium 10 Cefazoline Sodium 11 (Amikacin Sulfate ) 12 Gentamicin Sulfate 13 Chloramphenicol 115
14 Tetracycline Hydrochloride 15 (Doxycycline Hydrochloride ) 16 Erythromycin 17 Lincomycin Hydrochloride 18 Compound Sulfamethoxazole 19 Sulfadiazine 20 [ Ciprofloxacin ] Hydrochloride,Lactate 21 ( Norfloxacin ) 22 ( Ofloxacin ) 23 Metronidazole 24 ( Nitrofurantoin ) 116
25 Furazolidone; Nifurazolidone 26 Methenamine 27 ( Berberine Hydrochloride ) 28 Sodium Aminosalicylate 29 Rifampicin 30 Streptomycin Sulfate 31 Ethambutol Hydrochloride 32 ( )Isoniazid 33 Dapsone 34 Acedapsone 35 Nysfungin 36 Aciclovir 37 ( Ribavirin ) 38 Praziquantel 39 Bithionol 117
40 Diethylcarbamazine Citrate 41 Quinine Sulfate 42 Primaquine Phosphate 43 Chloroquine Phosphate 44 Dihydroartemisinin 45 Mebendazol 46 Levamisole Hydrochloride 47 Pentamidine 48 Sodium Stibogluconate 49 Aspirin 50 Ibuprofen 51 Somedon 52 Allopurinol 53 Colchicine 54 Enflurane 55 Isoflurane 56 Thiopental sodium 118
57 Ketamine Hydrochloride 58 Lidocaine Hydrochloride 59 Bupivacaine Hydrochloride 60 Tetracaine Hydrochloride 61 Procaine Hydrochloride *62 Fentanyl *63 Morphine Hydrochloride *64 Pethidine Hydrochloride 65 Suxamethonium Chloride 66 Ephedrine Hydrochloride 67 Naloxone Hydrochloride 68 Calcium Gluconate 69 B1 Vitamin B1; Thiamine 70 B12 Vitamin B12; Cyanocobalamin 71 B6 Vitamin B6;Pyridoxine 72 C Vitamin C; Ascorbic Acid 119
73 D3 Vitamin D3; Cholecalciferol 74 Arginine Hydrochloride 75 Fat Emulsion 76 Corticotrophin 77 Desmopressin 78 Chorionic Gonadotrophin 79 Dexamethasone Acetate 80 Prednisone 81 Hydrocortisone 82 Nandrolone Phenylpropionate 83 Testosterone Propionate 84 Methyltestosterone 85 Diethylstilbestrol 86 Medroxyprogesterone Acetate 120
87 Progesterone 88 [ Insulin ] 89 Neutral Insulin 90 Protamine Zinc Insulin 91 Glibenclamide 92 Metformin Hydrochloride 93 Thyroid Tablets 94 ( Compound Iodine ) 95 Propylthiouracil 96 ( Thiamazole ) 97 Tripterysium Glucosides 98 Azathioprine 99 Cyclophosphamide 121
100 Thiotepa 2000-12-22 122
2001-1-8 2001-1-8 123
2000-10-31 1019 20 124
FDA 5 2000-12-18 5 1365 300 125
55.65 2001-1-4 1215 115929 55.65 5 768 2600 126
( ) ( ) ( ) ( ) ( ) 2001 70-80% ( ) ( ), 127
, ( ) ( ) ( ) 2000-12-22 1121 128
5 3 15 3 18 10 472 1130 1200 600 1536 657.2 10 GB-1993 ( )115929 55.65 129
10098 28.97 7000 130
2000-12-12, 3 131
17 2000-12-4 132
2001 ( ) 133
12 2001 134
135
1 2000-11-28 1 9 10373 28.16% 334 136
9.50% 25 56.25% 1 1. 3 2.,, 1 9 3 13.96% 99.7% 3., 9 8159 78.67% 4., 137
2000-12-18 138
2000-12-8 1116 17 2 139
2000-11-27 1114 50 140
1/3 ( ) ( ) 141
2000-11-27 1018 142
143
2000-10-27 28 144
145
2000-12-4 1122 28 ( ) 146
GMP 147
2000-10-31 1011 6 6 1200 600 500 93 768 148
52 300 GMP 8 GMP 2000-10-26 1018 149
1200 150
151
2000-12-1 () 152
100 20013 17 153
2000-12-9 154
155 1115 30 2000
2000-12-9 1121 17 17, 156
5 3 427 1130 1200 50093 768 98 2600 157
1123, 4 10 200 500 2 5000 80 158
40 170 83.56 3 18 10 2000-12-21 126, 5, 5 159
3 2000-10-26 160
161
2000-12-28 29 2 2000-12-25 162
163 11 110 80 4 3 10 123 40
164 40 124 88 30 100 4 12 1 2 140 4 4 1026 28 2.6 6 10 110 80
2000-12-5 2000 11 28 85 165
166
WTO 167
2000-12-7 300, 21 2b 168
169
18 60 14 170
( ) (1994) Z-B-0093 20062 ( ) (1994) X-B-0021 20012 ( ) (1994) X-A-0087 10058 ( ) (1994) Z-B-0013 20019 ( ) (1994) Z-B-0011 20016 ( ) (1994) 171
X-A-0047 10028 (1994) 10103 ( ) (1994) X-B-0135 20132 ( ) Z-C-0038 ( ) (1994) X-B-0114 20136 ( ) X-A-0155 (1995) 387514 (1993) 172
2000 387507 (1994) 387508 2001-1-4 2000 2000 10070 973 9.66 173
6.06 3.45 7.9013.84 9.41 4.93 6.454.03 143 112 146 18 19 25 174
1504 403 320 6 383 500 40 2000-12-7 175
1128 6 176
177 () 0791-6217821
178
GMP GSP 179
2000-12-11 2001 2001-1-2 2001-1-2 2001-11-2 180
10 35 12 () 181
10 35 2000-12-6 1120 182
2000-12-6 1013 1120 183
184
185
2000-12-6 1120 186
1. 2. 187
3. 188
189
2001-1-10 2001-1-10 30 50 190
2000-11-1 1019 33 191