International Cooperation, Convergence and Harmonization of Pharmaceutical Regulations

International Cooperation, Convergence and Harmonization of Pharmaceutical Regulations: A Global Perspective provides the current status of the complex and broad phenomenon of cooperation, convergence and harmonization in the pharmaceutical sector (Part I), thoroughly evaluates its added value and its critical parameters and influencing factors (Part II) in order to recommend actions and measures to support the next steps for cooperation, convergence and harmonization (Part III). All of these recommendations in the book support the establishment of a better coordinated global pharmaceutical system which represents the best realistic alternative to fulfill the objective to establish a global coalition of regulators and to respond to an increased demand to further cooperation in the pharmaceutical sector. This proposed framework, which leverages all of the ongoing positive cooperation initiatives and uses as foundations all of the numerous harmonization projects developed over the years, presents advantages for all stakeholders and would definitively have significant added value to the promotion and protection of global public health.

• The status of all major worldwide harmonization and cooperation initiatives (at bilateral, regional, and global levels)
• The value of cooperation in the pharmaceutical sector and the driving factors behind harmonization
• The proposition of a structure for the global pharmaceutical system and timely recommendations for enhancing international cooperation, as well as further discussion and policy changes in this area

Regulatory professionals from pharmaceutical companies, academia and regulatory agencies worldwide, as well as students in regulatory affairs programs

Dedication

Preface

About the Author

Foreword by Professor Stuart Walker

Introduction

Part I. State of Play and Review of Major Cooperation Initiatives

Abstract

I-1) Global Initiatives

I-2) Regional Initiatives

I-3) Bilateral Initiatives

I-4) Other Cooperation Initiatives

I-5) Conclusion

Part II. Value and Influencing Factors of the Cooperation, Convergence, and Harmonization in the Pharmaceutical Sector

Abstract

II-1) Value of the Cooperation, Convergence, and Harmonization in the Pharmaceutical Domain

II-2) Critical Parameters and Influencing Factors for Cooperation, Convergence, and Harmonization

Part III. Recommendations to Support the Next Phase of International Cooperation, Convergence, and Harmonization in the Pharmaceutical Domain

Abstract

III-1) Overview and Key Principles of the Proposed Global Pharmaceutical System

III-2) Recommendations

Conclusion

Acronyms and Abbreviations

List of Figures, Tables and Plates

Figures

Tables

Color Plates

List of References

Index

Color Plates