20130530 衛環委員會 - 102年度衛生署主管預算解凍案
TRANSCRIPT
-
8 3
102
()
-
.. 1 ~ 3
. 3 ~ 6 8
... 69~75
.. 75~80
.. 81~87
.. 87~96
.. 96~110
1 94 5 27 0940013923. 111~112
2 1..... 113
3 1 6. 114
4 101..... 115~117
5 101102..... 118~121
-
1 110
102
102
102 81 13 4,483 9,001 1 362 8,000 50 10 0,513 1,001 4 1,177 8,000 5 4,261 8,000 5 500 9 2 4,474 2,000 7 3,194 2,000
() 22 ()
()5,618 8,000 1,814
-
2 110
1. 102 1,814 95 3 7 0950061139 95 1 2 0940037980
20,700 50,000
2.
3. 94 5 27
0940013923 71 9 15 71 26056
1
4.
-
3 110
() ()
50,000 2 50,000 6
45,000 1 50,000 1
50,000 1 50,000 1
(9 ) 45,000 2
(7 ) 34,000 1 50,000 2
() 41,400 1
50,000 1 ( 14 1 ) 41,400 3
41,400 3
( 13 1 ) 34,500 1
50,000
5.
() 1 ()
5,993
1.
-
4 110
58 96 100 176 132 13 8 23 64 97 6
2. 30
95 98
96 10 27
3. (1).
7 94(65)79( 56 ) 84%( 86%)
(2). 102 (101 ) 202 162 18 22 5,000~6,000
(3). 101
102 105
26 101 105
-
5 110
206 4.
5. 200 4
200
6.
() 1 ()
7,017 5
1.
58
422 96 100 176 132 13 8 23 64 97 6
2. 30
95 98
96 10 27
3. 5
-
6 110
5
102 2 5,000
4.
() 1 ()
4,896 0-3
1.
7 ()7
2. 3 1.5-2
-
7 110
3. e
4.
5.
6.
7. Taipei-II
8.
9.
-
8 110
3
10. 0-3
() 1 ()
4,885 6,000
1.
(1).
I. 967
II.
(2).
-
9 110
I.
II.
5
III.
IV. 100-102
65
2.
(1).
(2).
(3). ()
-
10 110
967
(4).
I. i.
ii.
102
II. i.
ii.
100
-
11 110
101 7 3
iii.
3.
() 1 ()
1,278
1.
101
2. 101 12 28
-
12 110
3. 101 12 101 12 22
4.
9 102 2 6
5.
100
6.
() 1 ()()()
3,192 4,000
-
13 110
1. 6 1 4
()
2.
ID
3.
()
GIS
-
14 110
4.
5.
(VPN)
e-mail 6.
100 134 101 166 24%
7. 102 ISMS() PIMS()
8. 101
706 4,000 102 620 101 3,150 102 2,572 4,000
9.
-
15 110
() 1 ()
22 6,076 4,000 102 101
()
1. ()
2.
3.
(GRB )
4. 101 102
-
16 110
() 1 ()
16 0,249 6,000
1.
2.
3.
4.
-
17 110
() 1 ()
cGMP 1 2,687 9,000
71 71
1. 102 1 4 71
2.
71
3.
() 1 ()()
cGMP 1 2,687 9,000 102 95 6,300 49
1. (cGMP)cGMP
cGMP
-
18 110
6,300
70 2. 100 1 59,00
102 1 2,937 9,000 cGMP 6,300
3. (1). 101 11
5
(2).
(3).
(4).
4.
-
19 110
() 1 ()
cGMP 1 2,687 9,000
1. cGMP
102
(1).
GMP
(2). (H5N1)
(3).
(4). 71
(5). 102
(6). B (IND)
-
20 110
2. cGMP
() 1 ()
cGMP 1 2,687 9,000 102
1. cGMP
102 (1).
GMP
(2). (H5N1)
(3).
(4). 71
(5). 102
-
21 110
(6). B (IND)
2. cGMP
() 1 ()()
- 1 8,482 8,000
1.
(1). (2).
(3).
()
2.
-
22 110
(1).
(2).
(3). (4).
3.
(1).
(2).
(3).
DNA
knowledge gap
4.
-
23 110
(NTP)
5. 3 29 (PM2.5)
6.
() 1 ()
- 1 8,482 8,000 PM2.5
1. PM2.5
2.
-
24 110
TSPPM10 PM2.5
(1).
(2).
(3).
(4).
(5).
3. 95
-
25 110
103
4. 3 29 (PM2.5)
5. PM2.5
() 1 ()
3,156 3,000
()
1. 35 1/2 1/3 18 ( 12 5 1 ) 17 ( 10 5 2 )
-
26 110
2 2. 2
35 10 6 1
3.
6 3
4.
() 1 ()
3,156 3,000
1. 102 1 1
4 5,000
2.
-
27 110
( 1 9,047 )
102 1 24
3.
4. 4.91%
-
28 110
102 4 30
5.
() 1 ()()()
570 4,000 () 101 1/3
1. 102 101 6
:
101 80 35 115
102 76 45 121
-
29 110
2. 5 3
()102
3. ()
4. 102 100 1 4()
5. 102
1.
505
2.
318 6,000
-
30 110
3.()
206 5,000 1.
161 5,000
2.45
4. 27 3,000 1.
30 15 2,000
2.12 1,000
6. 35 1/2 1/3 18 ( 12 5 1 ) 17( 10 5 2 ) 2
7.
-
31 110
() 1 ()()
1,724 3,000 102 1 1
1.
101 8 102 104 101 10 9 10101444186 102 1 1 5
2. (1). 84 3 1
5 101 12 31 160 4 102 1 1
102 1 1 6
(2). 101 10 30
-
32 110
6
3.
() 1 ()
145 4.91%
1. 102 5.17% 4.91% 4.91% 4.7% 206 105
2. 100 1 26 3
36%102 145 50 () 1 7
-
33 110
3.
() 1 ()
9,473 6,000
1. 101 11 22
23
2.
(1). 8,134 4,000
7,351.4 33,333.15 (4.53 ) 550 1,450 (900 ) 700 1,500( 800 )
-
34 110
(2). 1,159
(3). 180 2,000
3.
() 1 ()
1,159 100 28.23%
1. 100
28.23% 2. 102 1,159
( 100 1,028 9,000 ) 102
(1). 759 10
-
35 110
I.
23 1
9 540 60 9=540
II. 12 23 32
III.
187 IV. 10
(2). 320
(3). 70
3.
() 1 ()
8,134 4,000
1. 101 11 22
-
36 110
23
2.
8,134 4,000
3. 7,351.4
33,333.15 ( 4.53 ) 550 1,450 ( 900 ) 700 1,500 ( 800 )
4.
(1). 65 6,000 (2). 1,375
6,000 660 5,000
(3).
118 (4). 31 5,000 (5).
59
-
37 110
5,000 (6). 121 6,000
2 93 4,000 (7).
311 (8). 1,000 (9). 432
1,000 (10).
4,318 7,000 (11).
225 (12). 203 9,000
(13). 117 9,000
5.
() 1 ()
24 2,536 9,000
-
38 110
1.
100
2. 102 2 26 2.3.7
102 4 23 102 103 104
3. 101 5 10 6 10 10
4. 101 12 141,007 101 4 136,415 4,592 102 2 101
5. 101 5 101 12 2,829 1,670 1,159
6. 102
-
39 110
() 1 ()
724 7,000
1. 96
(1). 39
500
(2). 101 1 11 34,114 30,236
(3). 101 1 11
3,054
2.
7 800
-
40 110
() 1 ()
4,603 3,000
1. 101 12 28
2. 102 2 1
1020268925 3. 102
105
4. 5.19 5 102 1 370 103 1 370
5.
-
41 110
() 1 ()
4,603 3,000
1.
2. 102 3 26
3.
() 1 ()
666 8,000 82
1.
-
42 110
2.
3.
101
9 511 12
4. 82 1 101 10 12 18 102 1 4
5.
() 1 ()
1 2,835 6,000
1. 6 8 102 3 27
-
43 110
102 7
2. 100 150 4 1
3.
75
4.
103 104
5. 101 12 24 102 1 22
6.
103
-
44 110
7. 102 7
() 1 ()
2,314 1,000
1.
(1).
100
(2). 102 2 26
2.3.7
102 4 23 102 103 104
(3).
-
45 110
102
2. (1). 97
e
(2).
(3).
98 49 14 71 10
(4).
-
46 110
(5). 508 238
3.
() 1 ()
4 4,000
1. 102
2. 102 724 7,000
101 900 100 1,000 175 3,000 275 3,000
3.
-
47 110
() 1 ()
4,274 5,000
100
1.
2. 99 101
418 16,250 100 34,497 99 31,792 8.5 101 202,547
3.
102
102 4
4. 100 10 24 11 10 10
-
48 110
5.
101
(1).
(2). Anti-HIV
(3).
(4). Time Out
6.
() 1 ()
20 7,515 3,000
1. 96-100
-
49 110
15% 23% 5%
0.47 1.12(Gini) 97 99 0.2090.20900.213
2. 4
(()
)
96 100 65 68 102 79 78 102 2 101 14 12 86%
3.
(1). 14 2
11 4,000 (2). 99%89
-
50 110
(3). 134 14
10
(4). 39 88 101 1,325
4.
() 1 ()
72
1. 101 5
48 1 1,300
1,300 50%
-
51 110
2.
/
3. 102 88 102 103 104
() 1 ()
11 4,000
1. 99 12 21
2. 100 8 1
-
-
52 110
3. 2
1 102 3 ( 3 ) 11 4,000
4.
() 1 ()
1,440
1.
101 12 10
2. /
-
53 110
()() 102 4 1
3. 102 4 24
()
1
4. 102 3 27
()
-
54 110
5.
102 4 1
() 1 ()
1,440
1. 101 12 10
2.
102 4 1 (1)
(2)()
-
55 110
;() 2
(3)()
3. 102 4 24
()
1
4.
-
56 110
() 1 ()
7,221 6,000
1. 98 2 98 101
98 4,406 10 14.7 99 3,889 13.8 100 3,507 12.3 3 99 2 10 100 12
2. 102
-
57 110
3. 102 98
6 1,284
102 7 500
4. 102
5,000 6
5. 102
6.
-
58 110
() 1 ()
7,221 6,000 30 3.2% 101 8
1. 101 12
2.
30 30
3.
4.
3
-
59 110
5.
() 1 ()
6 9,253 7,000 52
1.
97 2.3% 101 12 27% 12
2. 100 99 1.1 101 100 1.14
3 3.
(1). I. 101 2,702 8,000
101 7 101
-
60 110
1,143 8,000 101 3,846 6,000 102
5,441 8,000 (2).
I. 102 27%
(3). I.
II.
III.
ADLIADL CDR 21
IV.
(4).
(5).
-
61 110
() 1 ()
3 1,814 6,000 99
1.
2.
3.
101 275 99 28 9.24%
4.
-
62 110
93 105 101~105
153
5. 101
6. 101: (1). :
(2). :
(3). :
(4). :
1-3
(5).
-
63 110
7.
() 1 ()
31 2,333 6,000
1. 26
90 102 56%56.5 24.51
90 101 146 213.56 46.27%101 100 6 6 4
2.
-
64 110
3.
(1)
I.
i.
ii.
iii.
41.01%45.54%47.13%
II.
i.
ii. 500 1,000 3
102 3 126 12 102 17 7 (
-
65 110
)
(2)
(3)
(4)
4.
() 1 ()
31 2,333 6,000
1. 91 1 31
09102101431
2.
(1)101 6 4
-
66 110
20
(2)101 11 13
56 2 2
(3)101 12 12
I. 8 1 ()
II.
3.
4.
-
67 110
() 1 ()
3 1,544
1. 96 10 2
96 10 31 92 4 14 0920018915 3 8
(1).
(2).
99 8 2 0990041111 4 8
I.
-
68 110
II. 99 4 27
99 5 6 92 4 14 8 2
2.
99 12 17
3.
4. 101 3
101 12
5. 102 1 6 102 4 4 102 5 9
6.
-
69 110
() 2 ()
3,389 1,000 99 100
1.
(WHO) 99 101
2. 101 207
92 97 NS1
50~90%
3.
-
70 110
4. 101
(WPRO)
5.
() 2 ()
4,423 3,000
1.
2.
-
71 110
NS1
3.
3,000
4. (WHO)
() 24
(1).
(2). 24
50
5.
-
72 110
6.
3 10
7.
8.
() 2 ()()
1 9,567 4,000
1.
2. 4 5 (96-100
-
73 110
) (1). 4:1~5.5:1
2005 2008 15,000 300 44 8 1 4-5.5
(2). HAART 18:1 HAART HIV 0.391HIV 0.184 53%5 5,000 22 31 65 1,400 32 79 30 1,400 2,800 5,000 1,400 5 HAART 78 18:1 1 HAART 18
3. 101 I-Check
197 112
4.
-
74 110
5. :
(1). () ()
(2).
(3).
(4).
(5). :
(6). :
-
75 110
(7).
100 21 0,748 101 20 4,411
6.
() 3 ()
785 5,000
1. 6
102 4 15
2. 85 2010 194 2 8 3 12 4 10 5 6
-
76 110
7 164 20 OECD
3. 2008 2011
1 1 0.6
4. ( GBS )
5.
6
5 2018 2.1
6. - 4
-
77 110
() 3 ()
27 2,397 3,000
1. 3 102 2 23
2. 7 7
3. 101 12 4
1 2 100 /
4.
7 (1) 1 1
(2) 4-10 3
-
78 110
5.
6.
() 3 ()
27 2,397 3,000
1. 84 1 4 84 1 16 84 10 25.3 98 11.9 53%84 10 11 100 4.1 63% 10 4-5
2. 2-3 1 3 1 3 1 99 -102
30-69 3
-
79 110
3. 3 1 3 1 3 3 1
4.
() 3 ()()
27 2,397 3,000 97
1.
7-4 16
2. 32 102 1 1 32 84 101
-
80 110
3.
94 2 18
95
97
98
4. 99 7 23
99 8 25
5. 103-106
102 3 27
6. 2,000
7.
-
81 110
() 4 ()
3,310 4,000
1. 3
88 324
91 101 323 209 114 101 8 1
10
18
-
82 110
2.
;
3.
101 1,179 257(21.8%) 234 ( 91.1%) ()134 57.3% 73 (31.2% 45 )
4.
() 4 ()
3,310 4,000
1.
-
83 110
2.
90 95
3.
4.
103
5.
-
84 110
() 4 ()
3,310 4,000
1.
(1). 9710
14
324
101
121507505299.6%
(2).
91
101323209114
(3). 10181
-
85 110
1032%
45%100%101811024301,6968,925218
2. 101
12 22 300
3.
() 4 ()
-
86 110
140
1.
;
2. 102
[( )( 1,000)x100%] 95%
3.
() 4 ()
982 8,000
1.
101 8 1 10 10
-
87 110
2.
4
3.
4.
() 5 ()
5,186 2,000()
1. 102
-
88 110
4
2. 102
16 2~3
102 100
100 102
3.
100
4.
() 5 ()()
5,186 2,000
-
89 110
1. 5
49
2.
39
15,000()
3. 102 - 16 100 800 8
5,000
100 101 102 4 5 3
4.
-
90 110
() 5 ()
400
1.
100 7 1 8 3 () 20 3
2. 101 3 1
3.
()
(1).
()
-
91 110
(2).
call center
4. 101 4 (99 7 -100 6) 3 3 ( 1 2 ) 1 ()
5.
6.
101
(1).
-
92 110
(2).
(3). (4).
(5).
7.
() 5 ()
7 6,211 1,000 4 2,251 4,000
1. 84 700
84 2 8 04391
-
93 110
2.
84 10 12 36085
3. 102 4 5 99.69% 99.27%
4.
() 5 ()
4 2,251 4,000
1. 84
84 10 12 36085
2. 102 4 5 99.69%
3.
-
94 110
() 5 ()
315 6,000 (Tw-DRG)
1. Tw-DRG 5 99 1 Tw-DRGs 1 2
DRG 2
2. 100 6 101 8
101 12 1 DRG
101 12 1 102 4 30 102 4 19 102 9 30
3. DRG 2 100 11 18 102 5 17 2 102 2
4. 1 Tw-DRGs 101 12
-
95 110
98 1-12 4.39 101 12 4.13 5.92%98 1-12 45,511 101 12 45,320 0.42% Tw-DRGs
4 5. DRG
101 8 - Tw-DRGs
6.
7.
() 5 ()()
4,118
1. 6
-
96 110
2.
101 2,238 102 4 715
3.
4.
() 6 ()
6,109 5,000
-
97 110
1. 90 2 22
92 1 1
WHOFAO OECD 89 11 7
(CODEX) 97 8 20 99 9 9
97 5 6
-
98 110
2.
90 2 22 (1).
9293 94
(2).()
90
3.
(1).
(2).
-
99 110
I. (Identity Preservation, IP)IP 0.1%
II.
i.
ii.
4.
-
100 110
102 103
5.
() 6 ()
311 4,000 100 101 1-6
1. 99 4
NCC 8
2. 100 101
99 4 -101 12 (1). 1,500
-
101 110
99 27.22% 101 12 2.16%99-101 13.03%4.65% 2.3%
(2). 99 1 14 101 12 4.7%
3. / 5
101 1-6
101 3 22 4.
5.
6.
-
102 110
() 6 ()
1 9,924 1,000
1.
2.
No Observed Effect Level, NOEL 10010 10
Acceptable Daily Intake, ADI
ADI
3.
4. 11
4
-
103 110
7
5.
6.
7.
() 6 ()
48 6,000
1. 100
-
104 110
(ICH-GCG)(CDER Forum)(FIP)
2. 101 ICH-GCG
3.
ICH (GCP)(CTD)(eCTD)
4. 101
( 4) 101102 ( 5)
5.
() 6 ()
1 1,678 1,000
-
105 110
1.
6
2. 800 3,000
3. 94
1,700
101
4. 102
(1). I.
(
-
106 110
) II.
4
(2).
(3).
I.
II.
III.
()
-
107 110
IV.
100 ()
5.
() 6 ()
2 5,743 2,000
1.
2.
101 3 20 9 12 210 6 2.86%
-
108 110
101 9 13 1,021
3.
(1). 151 151
()
(2). 220 213 10 ( 4.7%)
(3). 1000 1,116 8 ( 0.7%)
(4). 440 446
4. 101 9 12 11 20
33,550 99.8%
5.
-
109 110
6. 101 46 1,676 100 9.8%101 3 8,798 30.2% 1,648 7,676
7.
() 6 ()
2 5,743 2,000
1.
2.
101 2,363
-
110 110
2,121 ( 89.8%)
3.
101 (100 )
()( 215)
4.
102
-
113
1
()
()
()
()
2
-
114
1 6
// 1.
2.
3.
1.
2.
()
3.
1.
* (
)
2.
()
*
* ()
3.
1.
2.
()
3.
1.
*
2.
3.
1.
2.
3.
*
( )
3
-
101
115
101 (ICH-GCG)(DIA)
: 1. ICH-GCG(International Conference
on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use,ICH 1990
ICH 50 ICH ICH 1999 ICH Global Cooperation Group(GCG) 2 ICH APEC ICH 2008 ICHDepartment of Health (DoH) ICH-GCG 2 ICH-GCG ICH
2. DIA(Drug Information Association, DIA) 1964
ICH 2012 48
(Integrated Medicinal Product Review Office iMPRO)
4
-
101
116
MOU 3. 101 (1)
(2) APEC LISF RHSC(3) 2012
1.
2.
3.
4. ICH (GCP)(CTD)(eCTD)
()
-
101
117
-
118
101 ( 394)
()
(ICH-GCG) 110
101 11 10-17
MedDRA ADR Reporting System
8 104,360
101 6 23 7 1 48
TFDA 2
9 45,567 (DIA) 137
101 2 2-7 VII International Conference on Rare Diseases and Orphan Drugs(ICRORD): C3 : Connection + Collaboration = Creation
6 79,760 ( DIA)
101 8 20-25 APEC LISF RHSC IBC Asia[ 5th Annual Asia Pharmaceutical Regulatory Summit 2012]IBC Asia 2APEC LISF RHSC
6 30,024 147 101
101 9 24-29 2012
6 38,997
5
-
119
101 11 22-25
(2)
3 4
81,546
380,254
-
120
102 ( 486)
()
(ICH-GCG)102 1
5 1 136
(ICH-GCG)102 2
1990
ICH50 ICHICH 1999 ICH Global Cooperation Group(GCG) 2
4 1 58
GCP
GCP GCP 5 1 121
(WSMI)
WSMI NGO Self-Medication 50
WHO
5 1 70
American Association of Pharmaceutical Scientists (AAPS)
(American Association of Pharmaceutical Scientist, AAPS)
5 1 101
-
121
-
8 3
102
()
-
1
102
102102
-
2
81134,4839,00113628,000
50100,5131,00141,1778,00054,2618,0005500924,4742,00073,1942,000
()
102
-
3
-
4
1/5(2)
9537095006113995120940037980
-
5
-
6
1/10 (4)
7e
1/10 (3)
102
-
7
1/10 (6)
614
1/10 (7)
ID
1/10 (8)
-
8
(1/3) 1011/5 (85)
3,205(9)
71cGMP1/5 (86)
-
9
cGMP 10295491/10(10) (12)
(cGMP)70
cGMP1/10 (11) (13)
cGMP102 B
(2/3)
-
10
1/20 (14) (16)
329(PM2.5)
PM2.51/20 (15)
PM2.5329(PM2.5)
(3/3)
-
11
1/5(88)
. 102124
. 102430
-
12
1/5(87)
106
80(17)(18)
(1/2)
-
13
80(19)
()102 10014
(2/2)
13
-
14
1/5(89)90(20)
1018102
5
8431
-
15
-1(21)
1025.17%4.91%4.91%4.7%206105102-
-
16
1/5(90)(22)
1011122 23
1001/5(91)
100
-
17
1/5(95)
102
1/5(92)
7~800
51,000(23)
102
(1/6)
-
18
1,000(24)
102
(25)
8211011218 10214
2913,000(26)
(2/6)
-
19
1/2(27)
1/5(94)
200(28)
1024101
(3/6)
-
20
1,500(29)114,000
1/2(30)
(4/6)
-
21
-1/5(93)-(2/1)1023(3)114
800(31)
1011210()()77810241
(5/6)
-
22
800(32)1011210
--1/20(33)
1003,50712.33210WHO
--1/20(34)
3030
(6/6)
-
23
500(1)
96102710210526
500(2)
5
1/5(5)
1011222 910226
(1/2)
-
24
900 (35)
10227%
500(36)
10127599289.24%
(2/2)
-
25
500(37)
269010256%56.524.51146213.5646.27%
500(38)
500(39)
31,54410259
-
26
-
27
1/5 (8)
(WHO)
250 (1)
50~90%
(1/2)
-
28
500 (2)(3)
1.
2.()()
3.
4.5.6.7.181
(2/2)
-
29
-
30
1/3 (1)
6
520182.161024154
2,000 (2)
101124123 1022237
(1/2)
-
31
2,000(3)
33131331
972,000(4)(5)
103-106102327
(2/2)
-
32
-
33
500 (1)
(324)(91)(10181)
500 (2)
90103
500 (3)
3241011222
(1/2)
-
34
1/20 (4)
102 [()(1000)x100%]95%
1/10 (5)
101811010
(2/2)
-
35
-
36
()1/10 (1)
42~3
1/10 (2) (3)
10080085,000100101102453
(1/3)
-
37
1/5 (9)
3101
1/5 (10) (11)
1024599.69%99.27%
(2/3)
-
38
(Tw-DRG)1/5(12)
(Tw-DRG)1022
200 (4)
1/5 (13)
1012,2381024715
(3/3)
-
39
-
40
1/10 (1)()102103
1/10 (2)994
1/10 (3)
(1/3)
-
41
1/5 (15)
(ICH,DIA)MOUMRA
50(4)
500 (5)
(2/3)
-
42
500 (6)
(3/3)
-
43