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Food and Drug Regulation in an Era of Globalized Markets
1st Edition - August 31, 2015
Editor: Sam F Halabi
Paperback ISBN:9780128023112
9 7 8 - 0 - 1 2 - 8 0 2 3 1 1 - 2
eBook ISBN:9780128025505
9 7 8 - 0 - 1 2 - 8 0 2 5 5 0 - 5
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,… Read more
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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 pharmaceutical sectors in China and India.
From the changing nature of packaged and processed food supply chains, to the reorientation of pharmaceutical research and funding coalesced to confront firms, regulators, and consumers are now faced with previously unknown challenges.
Based on the 2014 O’Neill Institute Summer program, this book provides an international, cross-disciplinary look at the changing world of regulations and offers insights into requirements for successful implementation.
Interdisciplinary approach allows readers to understand the varying perspectives involved in regulatory development
Includes case studies to highlight harmonization efforts and challenges, and to provide practical insights for application going forward
Provides a thorough assessment of supply chains, potential gaps, and means of anticipating and addressing issues
Presents a comprehensive snapshot of changes in the food safety law in the United States and under international standards, including academic, industry and regulatory perspectives
Addresses conflicts and cooperation between relevant US agencies including USDA, FDA, DEA, EPA, FTC and the Department of Commerce
Academics and regulators from a wide range of low-, middle-, and high-income countries; legal professionals who mainly work in the food and drug regulatory space for North American and European firms who are increasingly accessing low- and middle-income markets for a number of reasons; and managers in major food and drug firms seeking to understand the next set of regulatory challenges
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
Abstract
Introduction
Approaches to Reduce Drug Development Costs and Speed Innovation
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
Abstract
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
Abstract
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
Transparency and the Centralized Procedure
EMA–FDA Cooperation
Benefits of International Cooperation
Chapter 4: Human Clinical Trials and Drug Approvals: Transnational Issues
Abstract
Introduction
Taking Clinical Trials Abroad
Overlapping Legal and Regulatory Requirements
Practical Considerations in Conducting Global Trials
Conclusion
Chapter 5: Falsified and Substandard Medicines in Globalized Pharmaceutical Supply Chains: Toward Actionable Solutions
Abstract
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
Abstract
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
Abstract
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
Abstract
Acknowledgments
China’s Political and Regulatory Goals: The Context for Drug and Device Regulation
Drugs
Devices
Increased Legal Penalties and Liabilities
Practical Tips
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
Abstract
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
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 National Food System
Abstract
Chapter 11: Global Administrative Law and the FDA’s Collaborative Agreements with International Regulatory Partners
Abstract
The Food Safety Modernization Act and the Prioritization of International Regulatory Partnerships
International Agreements: Typologies and Objectives
Conclusion
Chapter 12: Effective Regulation of Food Additives
Abstract
Pew’s Approach
Pew’s Findings
Pew’s Recommendations
Chapter 13: Protecting Consumers through New Regulations, Inspection, and Verification under the U.S. Food Safety Modernization Act
Abstract
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
Abstract
The Infrastructure of the Codex Alimentarius Commission
Organizational Structure
Leadership
Codex in Practice: A Brief Look at Some Global Challenges
Outside Influences
Codex in the Twenty-First Century
Chapter 15: The Emergence and Influence of Transnational Private Regulation of Food Safety
Abstract
Introduction
The Development of TPR in Global Food Safety Governance
Strengths of TPR of Food Safety
Weaknesses of TPR of Food Safety
Conclusion
Index
No. of pages: 264
Language: English
Published: August 31, 2015
Imprint: Academic Press
Paperback ISBN: 9780128023112
eBook ISBN: 9780128025505
SH
Sam F Halabi
Affiliations and expertise
The University of Tulsa College of Law, Tulsa, OK, USA