AC 兩岸經濟合作架構協議(ECFA)對生技產業之影響 2010.pdf

99

(ECFA)

99 11 30

0

........................................................................................ 1

........................................................ 3

......................................................... 3

....................................................... 15

................................................... 26

ECFA .......................................... 33

ECFA ............................................................... 33

....................................... 39

ECFA ...................... 45

............................... 45

............................................... 49

........................................................... 51

....................................................................... 52

.......................................................................... 57

.............................................................................. 61

1

(Economic Cooperation Framework

Agreement, ECFA)

ECFA

3

()

1980

1995

5

4

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

5

1

2010

6

2

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

7

2009 58

3

11.78

2008~2009 10

2008 2009 1 8.70 11.78 2 7.86 8.68 3 6.74 7.14 4 4.33 5.81 5 3.09 3.87 6 2.71 3.33 7 2.37 2.86 8 1.92 2.22 9 1.87 2.16

10 1.74 2.04 2010

2

8

2009 3

/

()

5

/

5

3

()

2001 200

2007 270

2009 262.80

2008 5%

9

2009 42 12

30 470

2009 25

124.2

()

3

2009 3

10

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

11

(Chemistry, Manufacture, and Control,

CMC)

2010 1 1

TFDA CDE

(Global New)

Biosimilart-NCE 2

(

(510K)) 2012

160100(510K)

90

12

1 2010

2 2010

TFDA

*expert

50%50%50%50%

(TFDA/CDE)

Global NewBiosimilart-NCE

CRO

TFDA

*expert

(TFDA/CDE)

75%75%75%75%

First-in Human

13

1 2 3 3

4

4 (Class I) (Class II) (Class III) (GMP) ()

(GMP)

(GMP)

() ()

()

2010

1

2 3

TFDA

3

14

3 2010

15

TFDA

()

(863 )2015

IMS Health 2011 3

2 2009

8,500 (1,241 )

20%

16

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%

9

17

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

18

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

5

19

5 2009 () ()

11938.9 8.2 10533.2 2.0 8496.4 3.2 5348.4 2.6 3257.7 1.8 1966.8 0.6 1941.1 0.5 1542.4 0.3 1523.1 0.7 1303.3 0.5

2010 ()

1

(State Food and Drug Administration, SFDA)

20

(1)

SFDA

SFDA SFDA

SFDA

SFDA

SFDA

SFDA

4

21

4 2007

22

(2)

SFDA

SFDA

5

23

5 2007

(3)

24

SFDA

GMP GMP

SFDA SFDA

2

3

SFDA

SFDA 2004 8 9

25

()

6

6 (

)

()

()

2004

5

()

SFDA

SFDA

26

()

()

6

6 2010

27

()

(WTO) 30

WTO

8-15%

3-6% 6%

7

7

29342943 05%1

46.5% 2050%

30013006

020%2 06.5% 070%

12091211 13011302

015%3 320%

1190% 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%

28

20%

8

8

HS6

() WTO

(%)

WTO

(%)

MW0()

MP1()

()

300510300590300610 7 3 3 5 300650 2 5 382200 1 5 5 4.5 401410401490481840 8 5 11.5~17.5 401511401519401590 5 5 8~18 660200600390 2 10 10~14 841869 2 1.778 10 871310871390871420 3 0 456 900130900140900150900190900311900319900390900490

1 13 3~10 8~20

900630901050901811901812901813901814901819

2 1 6 4.46 4~13.35

901841901849901850 2 2 0 4 901890 7 2 3 0 4 901910 1 2 0 9.5 901920902000 3 5 0 4~8 902110902121902139 16 0 4 902720902780 3 2 0 3.5 940210 2 0 0

2009

()

29

GMP

CGMP GMP 2014 PIC/S GMP

GMP

GMP

GMP

()

2008 7

2009 301

30

()

2

9

31

9

( )

() ()

IP

()

()

.

() one-stop-sho pping

8500

2010

33

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)

34

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

35

11

11

WTO

TBT

SPS

38

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

39

(

) 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 16.14ECFA ( http://www.ecfa.org.tw)2010

267

2009 28.6

40

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 10.53ECFA ( 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

41

14

8

(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

42

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

43

1/5

17%

ECFA

1/2

10%

ECFA

3

WTO

WTO

WTO WTO

45

ECFA

2010

6 29 ECFA

()

46

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

1

FDA CE

2005

4%

47

2011

2009 1.14

456

2

95069100

2009 4

80%

2009 3.64 2012

4,373

2

2

48

()

(CPC 851852853)

(CPC8510)

CRO

OECD

CRO

CRO

CRO

()

70%

35

ECFA

ECFA

49

ECFA ()

()

()()

ECFA

()

50

()(Good Laboratory Practices, GLP)

(Institutional Review

Board, IRB)

(Good Clinical Practice, GCP) NDA

GMP CGMPPIC/S GMP

GMPGCPGLP

()

51

1 2

3 SFDA

SFDA

()

ECFA

52

1 ECFA

()

8,500

2

3 ECFA

4ECFA

5

53

ECFA

ECFA

ECFA

ECFA

7

()

(((())))

54

(((())))

()

()

()

55

() ECFA

ECFA

57

ECFA

ECFA

ECFA

58

ECFA

ECFA

ECFA

ECFA

() ECFA

()

59

GLPGCPPIC/S GMP

FDA EMEA

()

() CRO CRO

CRO

()

61

1. (2010) 2010

2. 20102010

3. 2009ECFA 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

Documents

AC 兩岸經濟合作架構協議(ECFA)對生技產業之影響 2010.pdf