Food and Drug Regulation in an Era of Globalized Markets

Food and Drug Regulation in an Era of Globalized Markets

1st Edition - August 31, 2015

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  • Editor: Sam Halabi
  • eBook ISBN: 9780128025505
  • Paperback ISBN: 9780128023112

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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.

Key Features

  • 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

Table of Contents

    • 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

Product details

  • No. of pages: 264
  • Language: English
  • Copyright: © Academic Press 2015
  • Published: August 31, 2015
  • Imprint: Academic Press
  • eBook ISBN: 9780128025505
  • Paperback ISBN: 9780128023112

About the Editor

Sam Halabi

Affiliations and Expertise

The University of Tulsa College of Law, Tulsa, OK, USA

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