Regulatory Worlds

Regulatory Worlds
Author: Mark Findlay
Publisher: Edward Elgar Publishing
Total Pages: 233
Release: 2014-10-31
Genre: Law
ISBN: 1783470313

This ambitious book takes up the grand challenge to design regulatory thinking for a global future beyond wealth and growth, and towards social sustainability. Assuming a ŠSouth World� perspective on market regulation and social sustainability, the aut

The New Global Rulers

The New Global Rulers
Author: Tim Büthe
Publisher: Princeton University Press
Total Pages: 320
Release: 2011-02-28
Genre: Political Science
ISBN: 1400838797

Global private regulations—who wins, who loses, and why Over the past two decades, governments have delegated extensive regulatory authority to international private-sector organizations. This internationalization and privatization of rule making has been motivated not only by the economic benefits of common rules for global markets, but also by the realization that government regulators often lack the expertise and resources to deal with increasingly complex and urgent regulatory tasks. The New Global Rulers examines who writes the rules in international private organizations, as well as who wins, who loses--and why. Tim Büthe and Walter Mattli examine three powerful global private regulators: the International Accounting Standards Board, which develops financial reporting rules used by corporations in more than a hundred countries; and the International Organization for Standardization and the International Electrotechnical Commission, which account for 85 percent of all international product standards. Büthe and Mattli offer both a new framework for understanding global private regulation and detailed empirical analyses of such regulation based on multi-country, multi-industry business surveys. They find that global rule making by technical experts is highly political, and that even though rule making has shifted to the international level, domestic institutions remain crucial. Influence in this form of global private governance is not a function of the economic power of states, but of the ability of domestic standard-setters to provide timely information and speak with a single voice. Büthe and Mattli show how domestic institutions' abilities differ, particularly between the two main standardization players, the United States and Europe.

Regulating Medicines in a Globalized World

Regulating Medicines in a Globalized World
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
Total Pages: 169
Release: 2020-04-25
Genre: Medical
ISBN: 0309498635

Globalization is rapidly changing lives and industries around the world. Drug development, authorization, and regulatory supervision have become international endeavors, with most medicines becoming global commodities. Drug companies utilize global supply chains that often include facilities in countries with inconsistent regulations from those of the United States, perform pivotal trials in multiple countries to support registration submissions in various jurisdictions, and subsequently market their medicines throughout most of the world. These companies operate across borders and require individual national regulators to ensure that drugs authorized for use in their countries are safe and effective, and appropriate for their health care system and their population. This process involves significant resources and often duplicative work. It is important to consider how this process can be improved in order to better allocate resources, time, and efforts to improve public health. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators considers the role of mutual recognition and other reliance activities among regulators in contributing to enhancing public health. This report identifies opportunities for leveraging reliance activities more broadly in order to potentially impact public health globally. Key topics in this report include the job of medicines regulators in today's world, what policy makers need to know about today's regulatory environment, stakeholder views of recognition and reliance, as well as removing impediments and facilitating action for greater recognition and reliance among regulatory authorities.

The Brussels Effect

The Brussels Effect
Author: Anu Bradford
Publisher: Oxford University Press
Total Pages: 368
Release: 2020-01-27
Genre: Law
ISBN: 0190088605

For many observers, the European Union is mired in a deep crisis. Between sluggish growth; political turmoil following a decade of austerity politics; Brexit; and the rise of Asian influence, the EU is seen as a declining power on the world stage. Columbia Law professor Anu Bradford argues the opposite in her important new book The Brussels Effect: the EU remains an influential superpower that shapes the world in its image. By promulgating regulations that shape the international business environment, elevating standards worldwide, and leading to a notable Europeanization of many important aspects of global commerce, the EU has managed to shape policy in areas such as data privacy, consumer health and safety, environmental protection, antitrust, and online hate speech. And in contrast to how superpowers wield their global influence, the Brussels Effect - a phrase first coined by Bradford in 2012- absolves the EU from playing a direct role in imposing standards, as market forces alone are often sufficient as multinational companies voluntarily extend the EU rule to govern their global operations. The Brussels Effect shows how the EU has acquired such power, why multinational companies use EU standards as global standards, and why the EU's role as the world's regulator is likely to outlive its gradual economic decline, extending the EU's influence long into the future.

Regulatory Models for the Online World

Regulatory Models for the Online World
Author: Rolf Weber
Publisher: Springer
Total Pages: 224
Release: 2002-10-03
Genre: Computers
ISBN:

Global networks have become a major political, economic, and legal topic in discussions among the participants of the "global community". Around the world, governments, legal scholars, and practitioners are in the process of developing theories in respect of the regulation of the online world. These attempts are usually based on a given national "legal culture"; this approach, however, underestimates the importance of an "umbrella" concept. The purpose of this study accordingly consists in the comparative discussion of basic regulatory models (traditional government regulation, international agreements, self-regulation, code-based-regulation) and in the evaluation of their merits related to different topics that play a role in the online world (market entry, access, infrastructure stability, intellectual property, privacy, bad content, etc.). An easy solution is obviously not possible; however, a detailed examination on a comparative legal basis can give some insights for future regulatory initiatives.

Innovation and the State

Innovation and the State
Author: Cristie Ford
Publisher: Cambridge University Press
Total Pages: 374
Release: 2017-12-07
Genre: Law
ISBN: 1108514669

From social media to mortgage-backed securities, innovation carries both risk and opportunity. Groups of people win, and lose, when innovation changes the ground rules. Looking beyond formal politics, this new book by Cristie Ford argues that we need to recognize innovation, and financial innovation in particular, as a central challenge for regulation. Regulation is at the leading edge of politics and policy in ways that we have not yet fully grasped. Seemingly innocuous regulatory design choices have clear and profound practical ramifications for many of our most cherished social commitments. Innovation is a complex phenomenon that needs to be understood not only in technical terms, but also in human ones. Using financial regulation as her primary example, Ford argues for a fresh approach to regulation, which recognizes innovation for the regulatory challenge that it is, and which binds our cherished social values and our regulatory tools ever more tightly together.

International Health Regulations (2005)

International Health Regulations (2005)
Author: World Health Organization
Publisher: World Health Organization
Total Pages: 82
Release: 2008-12-15
Genre: Medical
ISBN: 9241580410

In response to the call of the 48th World Health Assembly for a substantial revision of the International Health Regulations, this new edition of the Regulations will enter into force on June 15, 2007. The purpose and scope of the Regulations are "to prevent, protect against, control and provide a public health response to the international spread of disease in ways that are commensurate with and restricted to public health risks, and which avoid unnecessary interference with international traffic and trade." The Regulations also cover certificates applicable to international travel and transport, and requirements for international ports, airports and ground crossings.

International Securities Regulation

International Securities Regulation
Author: Robert C. Rosen
Publisher:
Total Pages: 0
Release: 1986
Genre: International finance
ISBN: 9780379208252

Definitive and comprehensive, International Securities Regulation is the first treatise on international securities with translations of laws and regulations of 30 jurisdictions entirely in English. This seven-volume set encompasses the complete range of securities topics, including legal systems, securities regulatory schemes, descriptions of public securities markets, and discussions of those regulations regarding substantive securities matters. Lawyers, regulators, and professionals with first-hand, day-to-day experience have written commentary for each jurisdiction. Commentary focuses on each country's legal system, public securities markets, security regulations and implementations, and recent trends and developments.

Nutraceutical and Functional Food Regulations in the United States and Around the World

Nutraceutical and Functional Food Regulations in the United States and Around the World
Author: Debasis Bagchi
Publisher: Elsevier
Total Pages: 591
Release: 2014-02-25
Genre: Law
ISBN: 0124059120

This fully revised and updated edition begins with insights into the scope, importance and continuing growth opportunities in the nutraceutical and functional food industries and explores the latest regulatory changes and their impacts. The book demonstrates the global scenario of the acceptance and demand for these products and explores the regulatory hurdles and claim substantiation of these foods and dietary supplements, as well as addressing the intricate aspects of manufacturing procedures. As the public gains confidence in the quality of these products based on sophisticated quality control, a broad spectrum of safety studies and GRAS, peer-reviewed publications and cutting-edge human clinical studies have emerged. An increasing number of additional populations around-the-world now recognize the efficacy and functions of nutraceuticals and functional foods as established by those scientific research studies. As a result, a number of structurally and functionally active novel nutraceuticals and several new functional beverages have been introduced into the marketplace around the world. - Features fully revised and updated information with current regulations from around the world, including GRAS status and DSHEA regulators - Offers 45% new content including three new chapters –NSF: Ensuring the Public Health and Safety Aspects of Nutraceuticals and Functional Foods; Role of the United States Pharmacoepia in the Establishment of Nutraceuticals and Functional Food Safety; An Overview on the New Dietary Ingredient (NDI) and Generally Recognized as Safe (GRAS) Status, and the addition of cGMP regulations for dietary supplements - Includes insight into working with regulatory agencies, processes and procedures - Provides a link to the contact information for most regulatory bodies for readers wishing to gain further knowledge

Doing Business 2020

Doing Business 2020
Author: World Bank
Publisher: World Bank Publications
Total Pages: 254
Release: 2019-11-21
Genre: Business & Economics
ISBN: 1464814414

Seventeen in a series of annual reports comparing business regulation in 190 economies, Doing Business 2020 measures aspects of regulation affecting 10 areas of everyday business activity.