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2014 Taiwan Food and Drug Administration Next Page
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2014 Taiwan Food and Drug Administration Next Page

 




cover
I

Title Page
1

contents
2

Forward
4

01Policies andOrganization
6

Section 1 Administration Objectives and Highlights
7

Section 2 Organization Framework and Job Delegation
9

Section 3 Future Prospects
11

02 FoodManagement
12

Section 1 Food Laws and Regulations
13

Section 2 Food Product Source Management
16

Section 3 Food Product Safety Chain Monitoring
19

Section 4 Food Safety and Sanitation Management
22

03MedicinalProductsManagement
26

Section 1 Product Regulations and Registration of Medicinal Products
28

Section 2 Drug Product Sources Management
32

Section 3 The Product Quality Chain Monitoring
34

Section 4 Pharmacovigilance
38

Section 5 Controlled Drug Management
40

04Medical DevicesManagement
42

Section 1 Medical Device Regulations and Product Review
43

Section 2 Medical Devices Source Control
47

Section 3 Post-Market Quality Surveillance of Medical Devices
48

Section 4 Medical Device Safety Management
50

05CosmeticsManagement
52

Section 1 Cosmetics Regulations and Product Review
54

Section 2 Cosmetics Source Control
56

Section 3 Post-Market Quality Surveillance of Cosmetics
58

Section 4 Cosmetics Safety Management
59

06Risk Assessmentand RiskManagement
60

Section 1 Risk Assessment
61

Section 2 Risk Management and Emergency Response Mechanism
62

07The NationalLaboratory
64

Section 1 Mission of the National Laboratory
65

Section 2 Laboratory Function Enhancement
66

08LaboratoryNetwork
70

Section 1 Strengthening the Testing Capability and Quality ofLocal Health Bureau Laboratories
71

Section 2 Laboratory Accreditation and Management
73

Section 3 Mobilization for Emergency
76

09ResearchOutcomes
78

Section 1 Food Safety Control Research
79

Section 2 Medical Products Safety Quality Research
81

Section 3 Substance Dependence Integrated Research
84

Section 4 Nanotechnology Product Policy and ManagementResearch
85

Section 5 Agricultural Biotechnology and GeneticallyModified Organisms (GMOs) Research
87

10InternationalCooperationand Cross-StraitExchanges
88

Section 1 International Cooperation and Exchange
89

Section 2 Globalization of Laboratory Testing
93

Section 3 Cross-Strait Exchanges
95

11ConsumerProtection andAdvocacy
96

Section 1 Providing Immediate Information to Consumer
97

Section 2 Consumer Communication and Advocacy
99

12Major Events
104

Section 1 Illegal Starch Manufacturing Contamination Incident
105

Section 2 Illegal Cooking Oil Adulteration and Copper ChlorophyllTainting Incident
106

Section 3 The 2013 Act Governing Food SanitationAmendment
109

Section 4 Integrating into PIC/S as the Official ParticipatingAuthority
111

Appendix
114

Appendix 1 Annual Statistics
115

Appendix 2 Website Links
119

Imprint
120

Back cover
122