Featuring a comprehensive analytical collection of interdisciplinary research on regulatory authorities, this innovative Handbook combines contributions from leading scholars and regulatory practitioners to present the fundamental theoretical concepts, empirical achievements and challenges in the contemporary study of regulatory authorities.

'Political science has leap-frogged law, economics, and sociology to become the dominant discipline contributing to regulatory studies. David Levi-Faur's volume taps the rich veins of regulatory scholarship that have made this the case. It brings together the talented new network of politics scholars intrigued by the importance of the changing nature of state and non-state regulation. Their fresh insights complement important new work by established stars of the field. Definitely a book to have on your shelf when in search of exciting theoretical approaches to politics.' – John Braithwaite, Australian National University '"Regulation", in its manifold forms, is the central process of contemporary governance, as it seeks to blend the dynamism of market economies with responsiveness to political and normative demands for health, safety, environmental protection, and fairness. Understanding regulation's varieties, vulnerabilities, and virtues has become a significant focus of academic research and theory. This volume provides an extraordinary survey of research in that field – a survey remarkable in its comprehensiveness, outstanding in the quality of the contributions by leading regulatory scholars from different nations and academic disciplines.' – Robert A. Kagan, University of California, Berkeley, US 'An authoritative collection by a range of contributors with outstanding reputations in the field.' – Michael Moran, WJM Mackenzie Professor of Government 'This is an extraordinarily useful one-stop-shop for a wide range of traditions and approaches to the political aspects of regulation. David Levi-Faur has assembled a fine collection that by reporting on the state of the art also shows the way ahead for a discipline that has to capture and explain dramatic changes in real-world regulatory philosophies and policies.' – Claudio Radaelli, University of Exeter, UK 'This is an unusually impressive edited volume. Its contributors include the leading academic experts on government regulation from around the world. Its several clearly-written and informative essays address the most important topics, issues, and debates that have engaged students of regulatory politics. I strongly recommend this volume to anyone interested in understanding the breadth and depth of contemporary scholarship on the political dimensions of regulation.' – David Vogel, University of California, Berkeley, US This unique Handbook offers the most up-to-date and comprehensive, state-of-the-art reviews of the politics of regulation. It presents and discusses the core theories and concepts of regulation in response to the rise of the regulatory state and regulatory capitalism, and in the context of the 'golden age of regulation'. Its ten sections include forty-nine chapters covering issues as diverse and varied as: theories of regulation; historical perspectives on regulation; regulation of old and new media; risk regulation, enforcement and compliance; better regulation; civil regulation; European regulatory governance; and global regulation. As a whole, it provides an essential point of reference for all those working on the political, social, and economic aspects of regulation. This comprehensive resource will be of immense value to scholars and policymakers in numerous fields and disciplines including political science, public policy and administration, international relations, regulation, international law, business and politics, European studies, regional studies, and development studies.

Regulation is often thought of as an activity that restricts behaviour and prevents the occurrence of certain undesirable activities, but the influence of regulation can also be enabling or facilitative, as when a market could potentially be chaotic if uncontrolled. This Handbook provides a clear and authoritative discussion of the major trends and issues in regulation over the last thirty years, together with an outline of prospective developments. It brings together contributions from leading scholars from a range of disciplines and countries. Each chapter offers a broad overview of key current issues and provides an analysis of different perspectives on those issues. Experiences in different jurisdictions and insights from various disciplines are drawn upon, and particular attention is paid to the challenges that are encountered when specific approaches are applied in practice. Contributors develop their own distinctive arguments relating to the central issues in regulation and apply scholarly rigour and clear writing to matters of high policy-relevance. The essays are original, accessible, and agenda-setting, and the Handbook will be essential reading both to students and researchers and to with regulatory and regulated professionals.

More than 200 new infrastructure regulators have been created around the world in the last 15 years. They were established to encourage clear and sustainable long-term economic and legal commitments by governments and investors to encourage new investment to benefit existing and new customers. There is now considerable evidence that both investors and consumers-the two groups that were supposed to have benefited from these new regulatory systems-have often been disappointed with their performance. The fundamental premise of this book is that regulatory systems can be successfully reformed only if there are independent, objective and public evaluations of their performance. Just as one goes to a medical doctor for a regular health checkup, it is clear that infrastructure regulation would also benefit from periodic checkups. This book provides a general framework as well as detailed practical guidance on how to perform such "regulatory checkups."

Regulatory impact assessment (RIA) is the main instrument used by governments and regulators to appraise the likely effects of their policy proposals. This pioneering Handbook provides a comparative and comprehensive account of this tool, situating it in the relevant theoretical traditions and scrutinizing its use across countries, policy sectors and policy instruments. Comprising six parts, university researchers, international consultants and practitioners working in international organizations examine regulatory impact assessment from many perspectives, which include: • research traditions in the social sciences • implementation, regulatory indicators and effects • tools and dimensions such as courts and gender • sectoral case studies including environment, enterprise and international development • international diffusion in the European Union (EU), Americas, Asia and developing countries • appraisal, training and education. With its wealth of detail and lessons to be learned, the Handbook of Regulatory Impact Assessment will undoubtedly be of great value to practitioners and scholars working in governance, political science and socio-legal studies.

This handbook covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. It is the first to cover the medical device regulatory affairs in Asia. Experts from influential international regulatory bodies, including the US Food and Drug Administration (FDA), UK Medicines and Healthcare Products Regulatory Agency, Japan Pharmaceuticals and Medical Devices Agency, Saudi Food and Drug Authority, Korea Testing Laboratory, Taiwan FDA, World Health Organization, Asian Harmonization Working Party, Regulatory Affairs Professionals Society, and British Standards Institution, have contributed to the book. Government bodies, the medical device industry, academics, students, and general readers will find the book immensely useful for understanding the global regulatory environment and in their research and development projects.