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