ac 兩岸經濟合作架構協議(ecfa)對生技產業之影響 2010.pdf
TRANSCRIPT
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99
(ECFA)
99 11 30
-
0
........................................................................................ 1
........................................................ 3
......................................................... 3
....................................................... 15
................................................... 26
ECFA .......................................... 33
ECFA ............................................................... 33
....................................... 39
ECFA ...................... 45
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-
1
(Economic Cooperation Framework
Agreement, ECFA)
ECFA
-
2
-
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
-
32
-
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
-
36
-
37
-
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
-
44
-
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
-
56
-
57
ECFA
ECFA
ECFA
-
58
ECFA
ECFA
ECFA
ECFA
() ECFA
()
-
59
GLPGCPPIC/S GMP
FDA EMEA
()
() CRO CRO
CRO
()
-
60
-
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