Food and drug regulation in an era of globalized markets
Food and Drug Regulation in an Era of Globalized Markets provides a synthesized look at the pressures that are impacting today's markets, including trade liberalization, harmonization initiatives between governments, increased aid activities to low-and middle-income countries, and developing ph...
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| Main Author: | |
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| Format: | eBook Book |
| Language: | English |
| Published: |
Amsterdam
Academic Press
2015
Elsevier Science & Technology |
| Edition: | 1 |
| Subjects: | |
| ISBN: | 9780128023112, 0128023112 |
| Online Access: | Get full text |
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Table of Contents:
- Return Mobility to Cities Through Innovative Infrastructure Investments -- The Future -- Conclusion -- Chapter 10: Divide and Confound: The Relationship Between Transparency, Public Health, and Regulatory Authority in the Nat ... -- Chapter 11: Global Administrative Law and the FDA's Collaborative Agreements with International Regulatory Partners -- The Food Safety Modernization Act and the Prioritization of International Regulatory Partnerships -- International Agreements: Typologies and Objectives -- Confidentiality Agreements -- Statements of Cooperation or Intent -- Exchanges of Letters -- Memoranda of Understanding -- Systems Recognition -- Agreements Within Broader Bilateral Cooperative Partnerships -- Agreements or Quasi-Treaties -- Conclusion -- Chapter 12: Effective Regulation of Food Additives -- Pew's Approach -- Pew's Findings -- Conflicts of Interest -- Lack of Information -- Outdated Science -- Missing Safety Deadlines -- Pew's Recommendations -- Close the GRAS Loophole -- Modernize the FDA's Food Additive Science -- Ensure That Existing Chemical Additives Are Safe -- Establish a Fee-Based Funding Program -- Chapter 13: Protecting Consumers through New Regulations, Inspection, and Verification under the U.S. Food Safety Moderniz ... -- Introduction -- Preventive Controls for Human Food -- Produce Safety -- Foreign Supplier Verification Program -- Third-Party Certification Program -- Enforcement and Funding of the FSMA -- Chapter 14: The Evolving Role of the Codex Alimentarius Commission in Securing Consumer Protection in Globalized Food Markets -- The Infrastructure of the Codex Alimentarius Commission -- A Brief History -- Organizational Structure -- Leadership -- Codex Executive Committee -- Codex Secretariat -- Codex Subsidiary Bodies -- Codex Session Procedures -- Codex in Practice: A Brief Look at Some Global Challenges
- Internal Design -- Outside Influences -- Other International Institutions -- Industry -- Codex in the Twenty-First Century -- Chapter 15: The Emergence and Influence of Transnational Private Regulation of Food Safety -- Introduction -- The Development of TPR in Global Food Safety Governance -- Global Sourcing, Local Consumption -- Globalized Food Supply Chains and Outbreaks -- Reputational Risks to the Food Industry -- Public Distrust of Governmental Regulatory Reforms and a Shift of Responsibility -- Strengths of TPR of Food Safety -- Technical Expertise -- Effective and Efficient Cross-Border Supply Chain Control -- Regulatory Adaptability -- Cooperative and Proactive Nature -- Weaknesses of TPR of Food Safety -- Agency-Client Relationship, Checklist Governance, and Second-Level Information Asymmetry -- Legitimacy and Accountability Concerns -- Distributional Impact on Small Farmers and Developing Countries -- Conclusion -- Interactions Between TPR and National Authorities -- Interactions Between TPR and International Organizations -- Governance Through Constructive Interactions -- Index
- Front Cover -- Food and Drug Regulation in an Era of Globalized Markets -- Copyright -- Contents -- Contributors -- Foreword -- Introduction -- The Rise of a Global System for Food and Pharmaceuticals -- Conceptualizing Food and Drug Regulation in Globalized Markets: Interdisciplinarity and Governance -- The Plan of This Book -- Acknowledgments -- Acknowledgments -- Part I: Governance, Regulation, and Vulnerabilities of Globalized Pharmaceutical Supply Chains -- Chapter 1: Addressing Emerging Challenges in the Pharmaceutical Product Development Ecosystem -- Introduction -- Approaches to Reduce Drug Development Costs and Speed Innovation -- Clinical Trials: Reducing Costs, Speeding Development: New Approaches to Patient Recruitment, Study Design, and Settings -- Adaptive Design -- Clinical Trials: Globalization -- New Approaches to Endpoints: Biomarkers, Patient Reporting, and Remote Monitoring -- The Supply Chain: How Are We Vulnerable and What Are Potential Solutions? -- Big (More and More) Data: Swim or Drown? -- Conclusion -- Chapter 2: FDA's Global Investigation and Enforcement Authority, Partnerships, and Priorities -- Introduction -- Adulteration, Misbranding, and GMPs -- FDA Establishment Inspections -- FDA Enforcement Instruments Related to Manufacturing -- Foreign Inspections -- Conclusion -- Chapter 3: The European Medicines Agency and the Regulation of Medicines in the European Union -- 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 -- Patients 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 -- Chapter 4: Human Clinical Trials and Drug Approvals: Transnational Issues -- 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 -- Chapter 5: Falsified and Substandard Medicines in Globalized Pharmaceutical Supply Chains: Toward Actionable Solutions -- Globalization's Influence on the Pharmaceutical Supply Chain -- 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 -- Chapter 6: Regulatory Capacity in Low- and Middle-Income Countries: Lessons from the H1N1 Influenza Pandemic -- 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
- Chapter 7: Prime Minister Narendra Modi's Government and Its Impact on the Indian Pharmaceutical Sector -- 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 -- Chapter 8: Regulatory Challenges for Medical Devices and Drugs Under the China Food and Drug Administration -- China's Political and Regulatory Goals: The Context for Drug and Device Regulation -- Drugs -- 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 -- Part II: Designing Optimal Regulatory Structures to Address Diversifying and Globalizing Sources of Food and Additives -- Chapter 9: The Balance Between Regulation and Private-Sector Initiative in Securing Healthy and Sustainable Food -- Introduction -- Historical Context -- Challenge: Supporting Healthy Diets and Environmental Sustainability -- Narrow Scope of Nutrition Policy -- Lack of Investment in Broad-Based Solutions -- Relationship with the Private Sector -- Limited Capacity to Enforce Laws -- The Way Forward -- Foster New Models of Collaboration -- Embrace the Shift Toward Libertarian Paternalism -- Enhance the Role of Government -- Lever Core Capabilities of Companies -- Build on 40 Years of Partnerships Between Unlikely Partners