Food and drug regulation in an era of globalized markets:
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| Other Authors: | |
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| Format: | Book |
| Language: | English |
| Published: |
Amsterdam [u.a.]
Elsevier/AP
2015
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| Subjects: | |
| Online Access: | Inhaltsverzeichnis |
| Physical Description: | XLI, 215 S. 23 cm |
| ISBN: | 9780128023112 |
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| 245 | 1 | 0 | |a Food and drug regulation in an era of globalized markets |c edited by Sam Halabi |
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Titel: Food and drug regulation in an era of globalized markets
Autor: Halabi, Sam F
Jahr: 2015
Contents
Contributors
Foreword
introduction
Acknowledgments
xxv
XXI
xli
XI
Part I
Governance, Regulation, and Vulnerabilities of
Globalized Pharmaceutical Supply Chains
1. Addressing Emerging Challenges in the Pharmaceutical
Product Development Ecosystem 3
Jesse Goodman
Introduction 3
Approaches to Reduce Drug Development Costs and Speed
Innovation 4
Clinical Trials: Reducing Costs, Speeding Development:
New Approaches to Patient Recruitment, Study Design,
and Settings 6
The Supply Chain: How Are We Vulnerable and What Are
Potential Solutions? 10
Big (More and More) Data: Swim or Drown? 13
Conclusion 14
2. FDA's Global Investigation and Enforcement
Authority, Partnerships, and Priorities 15
Marc J. Scheineson
Introduction 15
Adulteration, Misbranding, and GMPs 16
FDA Establishment Inspections 18
FDA Enforcement Instruments Related to Manufacturing 22
Foreign Inspections 23
Conclusion 23
v
25
25
25
26
29
30
30
32
32
32
33
33
34
35
36
37
37
39
40
40
43
45
45
45
46
46
47
48
49
51
52
Contents
The European Medicines Agency and the Regulation
of Medicines in the European Union
Sabine Haubenreisser, Martin Harvey-Allchurch
Introduction
Approval of Drugs in Europe
The European Medicines Agency: Its Role and Activities
EMA Support in the Early Stages of Drug Development
The Centralized Procedure at Work
Assessment overview
Single Assessment Report
F^tients in the Scientific Review Process
Transparency and the Centralized Procedure
EMA-FDA Cooperation
Cooperation in the Product Life Cycle
Cooperation in Inspections
Benefits of International Cooperation
References
Human Clinical Trials and Drug Approvals:
Transnational Issues
Ben Haas, Shira N. Epstien
Introduction
Taking Clinical Trials Abroad
Overlapping Legal and Regulatory Requirements
Legal Landscape in the United States: FDA Oversight
of Clinical Trials
Legal Landscape in the EU: EU Clinical Trial Directives
and Regulation
International Legal Landscape: International Clinical Practice
Standards
National and Local Legal Standards
Practical Considerations in Conducting Global Trials
Deciding Whether to Conduct the Foreign Clinical Trial Under
an IND
Identifying Experienced Contractors and Contract Research
Organizations
Managing Idiosyncratic Foreign Sites and Investigators
Conclusion
Further Reading
Falsified and Substandard Medicines in Globalized
Pharmaceutical Supply Chains: Toward Actionable
Solutions
Sam F. Halabi, Lawrence O. Gostin
Globalization's Influence on the Pharmaceutical Supply Chain
Contents vii
The Effects of the Global Market for Falsified and Substandard
Medicines
Barriers to Global Solutions for the Problem of Falsified
and Substandard Medicines
Combating Falsified and Substandard Medicines through
Regulatory Cooperation
Conclusion
6. Regulatory Capacity in Low- and Middle-Income
Countries: Lessons from the H1N1 Influenza
Pandemic
Sam F. Halabi, John Monahan
Introduction
Pandemic Influenza: Background and Basics of Public Health
System Response
Pandemic H1N1 and the Global Response
Regulatory Barriers and Legal Barriers IMPACT Participation
in the Global Response
Lack of Regulatory Capacity Stymies Efforts to Distribute
Pandemic Vaccine after Legal Agreements Are Concluded
The Role of Investment in Regulatory Capacity and the
Effectiveness of the WHO Pandemic Influenza Preparedness
Framework
Conclusion
7. Prime Minister Narendra Modi's Government and Its
Impact on the Indian Pharmaceutical Sector
Vince Suneja
Introduction
Ministry of Health Family Welfare
Ministry of Chemicals Fertilizers
Ministry of Science Technology
Ministry of Commerce Industry
Ministry of Finance
Emerging Patterns in the Pharmaceutical Regulatory Environment
under the Modi Government
8. Regulatory Challenges for Medical Devices
ana Drugs Under the China Food and Drug
Administration
Gordon B. Schatz
China's Political and Regulatory Goals: The Context for Drug
and Device Regulation
Drugs
54
57
58
60
63
63
64
66
68
72
73
75
77
77
79
82
84
85
86
89
91
93
94
viii Contents
Patented and Generic Drugs
Registration
Clinical Trials
Manufacture and Sale of Drugs
Drugs That Have Been Licensed/Approved in Other Jurisdictions
Advertising
Anticorruption Compliance
Devices
Importing and Registering Medical Devices
Clinical Trials
Advertising Medical Devices
New Device Regulations—State Council Order No. 650
Registration and Filing Requirements
Clinical Trials
Increased Legal Penalties and Liabilities
Practical Tips
Acknowledgments
94
95
96
97
97
98
99
99
100
101
102
103
103
104
105
105
106
Part II
Designing Optimal Regulatory Structures to Address
Diversifying and Globalizing Sources of Food and
Additives
9. The Balance Between Regulation and
Private-Sector Initiative in Securing Healthy and
Sustainable Food 109
Eleanore Alexander, Derek Yach, Adriana Selwyn
Introduction 109
Historical Context 110
Challenge: Supporting Healthy Diets and Environmental
Sustainability 111
Narrow Scope of Nutrition Policy 111
Lack of Investment in Broad-Based Solutions 112
Relationship with the Private Sector 113
Limited Capacity to Enforce Laws 114
The Way Forward 115
Foster New Models of Collaboration 115
Embrace the Shift Toward Libertarian Paternalism 118
Enhance the Role of Government 119
Lever Core Capabilities of Companies 120
Build on 40 Years of Partnerships Between Unlikely Partners 121
Return Mobility to Cities Through Innovative Infrastructure
Investments 122
The Future 122
Conclusion 124
Contents ix
10. Divide and Confound: The Relationship Between
Transparency, Public Health, and Regulatory Authority
in the National Food System 125
Lisa Heinzerling
11. Global Administrative Law and the FDA's Collaborative
Agreements with International Regulatory Partners 135
Sam F. Halabi
The Food Safety Modernization Act and the Prioritization of
International Regulatory Partnerships 136
International Agreements: Typologies and Objectives 138
Confidentiality Agreements 140
Statements of Cooperation or Intent 140
Exchanges of Letters 141
Memoranda of Understanding 141
Systems Recognition 142
Agreements Within Broader Bilateral Cooperative Partnerships 143
Agreements or Quasi-Treaties 144
Conclusion 145
12. Effective Regulation of Food Additives 147
The Pew Charitable Trusts
Pew's Approach 150
Pew's Findings 151
Conflicts of interest 153
Lack of Information 154
Outdated Science 155
Missing Safety Deadlines 156
Pew's Recommendations 157
Close the GRAS Loophole 158
Modernize the FDA's Food Additive Science 159
Ensure That Existing Chemical Additives Are Safe 160
Establish a Fee-Based Funding Program 161
13. Protecting Consumers through New Regulations,
Inspection, and Verification under the U.S. Food
Safety Modernization Act 163
Chris Waldrop
Introduction 163
Preventive Controls for Human Food 165
Produce Safety 165
Foreign Supplier Verification Program 166
Third-Party Certification Program 167
Enforcement and Funding of the FSMA 168
x Contents
14. The Evolving Role of the Codex Alimentarius
Commission in Securing Consumer Protection in
Globalized Food Markets 169
Aliza Y. Clasner
The Infrastructure of the Codex Alimentarius Commission 172
A Brief History 172
Organizational Structure 172
Leadership 173
Codex Executive Committee 173
Codex Secretariat 173
Codex Subsidiary Bodies 174
Codex Session Procedures 176
Codex in Practice: A Brief Look at Some Global Challenges 176
Internal Design 1 76
Outside Influences 177
Other International Institutions 177
Industry 179
Codex in the Twenty-First Century 180
15. The Emergence and Influence of Transnational
Private Regulation of Food Safety 183
Ching-Fu Lin
Introduction 184
The Development of TPR in Global Food Safety Governance 186
Global Sourcing, Local Consumption 187
Globalized Food Supply Chains and Outbreaks 187
Reputational Risks to the Food Industry 187
Public Distrust of Governmental Regulatory Reforms and a Shift of
Responsibility 188
Strengths of TPR of Food Safety 189
Technical Expertise 189
Effective and Efficient Cross-Border Supply Chain Control 190
Regulatory Adaptability 191
Cooperative and Proactive Nature 191
Weaknesses of TPR of Food Safety 192
Agency-Client Relationship, Checklist Governance, and
Second-Level Information Asymmetry 192
Legiti macy and Accountabi I ity Concerns 195
Distributional Impact (Small Farmers and Developing Countries) 197
Conclusion 198
Interactions Between TPR and National Authorities 198
Interactions Between TPR and International Organizations 200
Governance Through Constructive Interactions 202
Index
205 |
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| title | Food and drug regulation in an era of globalized markets |
| title_auth | Food and drug regulation in an era of globalized markets |
| title_exact_search | Food and drug regulation in an era of globalized markets |
| title_full | Food and drug regulation in an era of globalized markets edited by Sam Halabi |
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| title_full_unstemmed | Food and drug regulation in an era of globalized markets edited by Sam Halabi |
| title_short | Food and drug regulation in an era of globalized markets |
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