99

(ECFA)

99 11 30

........................................................................................ 1
........................................................
3

......................................................... 3
....................................................... 15
................................................... 26
ECFA
.......................................... 33
ECFA ............................................................... 33

....................................... 39
ECFA
...................... 45
............................... 45

............................................... 49
........................................................... 51
....................................................................... 52
.......................................................................... 57
.............................................................................. 61

(Economic Cooperation Framework

Agreement, ECFA)

ECFA

()
1980
1995


2009

(value chain)

TFDA

()

2009 2,105
825
700 580 2009
2008 5%
2008 9%2009
1,300 50,650 717
1,483 2,871
1

PG2 H1N1

14 1
2

2010

Myozyome

Synpac (
)

2000
1,900 2007

Genzyme

Antibody 168

()

350

2005 5

Boehringer
Ingelheim

PBF-1681

()

100

2006 1

Keryx

PI-88

500

2007
Progen

TuNEX

()

()

2007 7
Bio
A&D

PG2

()

1,000

EcoPharm

GNX-X

2
()

Warner Chilcott

2010

2009 84
20

2009 58
3
11.78

2008~2009 10

2008

2009

8.70

11.78

7.86

8.68

6.74

7.14

4.33

5.81

3.09

3.87

2.71

3.33

2.37

2.86

1.92

2.22

9
10

1.87
1.74

2.16
2.04

2010

2009 3
/
()

5
/

5
3

()

2001 200
2007 270
2009 262.80
2008 5%

2009 42 12
30 470

2009 25
124.2
()

2009 3
9

 67 92.33
()
(Taiwan Food and
Drug Administration, TFDA)

(Investigational New
Drug, IND)(New Drug Application, NDA)
IND

CRO TFDA
(CDE)

IND 1

39 30

NDA TFDA

10

(Chemistry, Manufacture, and Control,

CMC)

2010 1 1
TFDA CDE

(Global New)

Biosimilart-NCE 2
(
(510K)) 2012
160 100 (510K)
90

11

CRO

TFDA

(TFDA/CDE)

First-in Human

*expert

75%

1
2010

TFDA

Global New

Biosimilart-NCE

50%

(TFDA/CDE)

*expert

2
2010

12


1 2 3 3
4

4
(Class I)

(Class II)

(Class III)

(GMP) ()

(GMP)

(GMP)

()

2010

1
2 3

TFDA
3

13

 3
2010

14

TFDA

()

(863 )2015

IMS Health 2011 3

2 2009
8,500 (1,241 )
20%
15

2009

10 100 (13.14 )

8 500 (65.72 )
2020 2 (2,629 )

()
2008
11,340 (1,632 ) 8,667
(1,247 ) 2007 25% 25%
1,171 (168 ) 1,298 (186 )
21% 1.77% 204 (29
) 2006~2008
23%

16


2009 10,382
(1,520 ) 2008 19.78%
2009

100 2009 100

10 5 100 100
2,981
30.97% 47
16 31
100
2009 11.98 2008 7.76%

69.58%

51.92%

2009 165.59 B6

87.4%2009

17

 10 8
77.13
67% 55.19%
2009 8,717.5 2008
53.16% 59.57%

77.99%
34.66% 8
96.55% 10

93.56%
43.91%
2009 5.5

18

 5 2009

()

()
11938.9
10533.2
8496.4
5348.4
3257.7
1966.8
1941.1
1542.4
1523.1
1303.3

8.2
2.0
3.2
2.6
1.8
0.6
0.5
0.3
0.7
0.5

2010

()

(State Food and Drug Administration, SFDA)

19

(1)

SFDA

SFDA SFDA

SFDA
SFDA
SFDA
SFDA
4

20

 4
2007

21

(2)

SFDA
SFDA

22

 5
2007

(3)

23


SFDA

GMP GMP
SFDA SFDA

2
3

SFDA
SFDA 2004 8 9

24


()

( ) (

(
)

2004

()

SFDA
SFDA

25


()

()
6

6
2010

26

()
(WTO) 30
WTO
8-15%
3-6% 6%

29342943

05%1

46.5%
2050%

30013006

020%2

06.5%
070%

015%3

320%
1190%

12091211
13011302

1. 0 2 29420010(2.5%)29420090(5%)
2. 0 3 30039071(20%)30049061(20%) 30061040(4.9%)
3. 0 8 12112010(5%)12112021(1.5%)12112022(1.5%)
12112031(5%)12112032(5%)12112090(5%)12119092(15%)12119093(7.5%)
2009

WTO 2009
10%

27

 20%
8

()

HS6

MW0()

300510300590300610

300650

382200

WTO
WTO

(%)
MP1()
()
(%)
3

5
5

4.5

401410401490481840

11.5~17.5

401511401519401590

8~18

660200600390

10

10~14

841869

1.778

10

456

13

3~10

8~20

4.46

4~13.35

871310871390871420
900130900140900150
900190900311900319
900390900490

900630901050901811
901812901813901814
901819

901841901849901850

2
2

901890

901910

9.5

901920902000

4~8

16

3.5

902110902121902139
902720902780

940210

2009

()

28

 GMP
CGMP GMP 2014 PIC/S GMP
GMP

GMP
GMP

()

2008 7
2009 301

29

()

30

(

)

()

(
)

IP

(
)

()

.

(

)
one-stop-sho
pping

8500

2010

31

32

ECFA

ECFA
ECFA
(North American Free Trade Agreement, NAFTA)

(ASEAN Free Trade Agreement, AFTA)

FTA

2009 2

2009
GDP 1.72% 5%
288 26

(World Trade Organization, WTO)

33

10

10 ECFA

* ECFA GDP 1.65%

~ 1.72% 4.87%~4.99%
6.95%~7.07%
*

2009

2009 12 22 4
5 2010 6 29
6

34

 11

11

WTO

TBT
SPS

35

36

37

ECFA ( http://www.ecfa.org.tw)2010

38

(
) ECFA
ECFA

539
2009
539 138.38
16.1 12

12
%

2009

88

59.44

6.93

107

11.43

1.33

136

15.88

1.85

50

1.48

0.18

140

49.97

5.84

18

0.16

0.02

539

138.38

16.14

ECFA ( http://www.ecfa.org.tw)2010

267
2009 28.6

39

 10.5 13
1:2 1:5
17

13
%

2009

42

3.29

1.21

69

1.16

1.75

22

4.74

0.43

17

4.09

0.02

117

15.30

5.64

267

28.58

10.53

ECFA ( http://www.ecfa.org.tw)2010

ECFA
(GNS/W/120)
(CPC, United Nations Provisional Central Product Classification,
ST/ESA/STAT/SER.M/77)
4

9
11 14

40

 14

(CPC862)
(842843 8439)
(851)
(87909)
(87907)
(96121)
(9311)
(8868)

(851852853)
(87909)
(87909)
(87907)

10
(621)
(96411 96412
96419)

1
3

ECFA (http://www.ecfa.org.tw)2010

()

10%~15% 2.5%~5%

ECFA 2 3
1
5% ECFA
1 5%
15% ECFA 1 5%ECFA
2 15% ECFA
1 10%ECFA 2

41

 5%ECFA 3
2
2.5%
ECFA 1 2.5%
7.5% ECFA 1
2.5%ECFA 2 7.5%
ECFA 1 5%ECFA
2 2.5%ECFA 3

()
1
18
18 13.3%2009
1,608 16.2 1%
ECFA 3
( 2009 223 )
1.1
2

42

1/5
17%
ECFA

1/2
10%
ECFA

3
WTO
WTO

WTO WTO

43

44

ECFA

2010
6 29 ECFA

()

45

2009 11.78

()

2 4% 12% 15

15
%

2009

90213100
114,496
4
0
95069110
364,432
12
0

(http://www.ecfa.org.tw)2010

FDA CE
2005

4%

46

2011
2009 1.14
456

2
95069100

2009 4

80%

2009 3.64 2012

4,373

47

()
(CPC 851852853)

(CPC8510)

CRO
OECD
CRO
CRO

CRO
()

70%
35
ECFA

ECFA

48

ECFA ()
()
()()

ECFA
()

49

()(Good Laboratory Practices, GLP)

(Institutional Review
Board, IRB)
(Good Clinical Practice, GCP) NDA

GMP CGMPPIC/S GMP

GMPGCPGLP

()

50

1 2
3 SFDA
SFDA

()

ECFA

51

1 ECFA

()
8,500
2

3 ECFA

4ECFA

52

ECFA

ECFA
ECFA

ECFA

7
(
)

()

53

()

(
)

(
)

(
)

54

(
)
ECFA

ECFA

55

56


ECFA

ECFA
ECFA

57



ECFA

ECFA

ECFA

ECFA
()
ECFA

()

58

 GLPGCPPIC/S GMP

FDA EMEA

()

() CRO
CRO

CRO

()

59

60

1.

(2010) 2010

2.

20102010

3.

2009
ECFA
2009.6.4

4.

(2010) ECFA
2010.8.4

5.

2010(ECFA)
2010.7.20

6.

2010(ECFA)
2010.7.20

7.

(2007)

8.

(2004)

1.

http://www.sfda.gov.cn

2.

http://www.ecfa.org.tw

3.

http://www.customs.gov.tw

4.

http://www.fda.gov.tw

61