International Regulatory Harmonization Research Articles

신경기술의 발전과 의료기기 규제의 국제표준화

With the recent growth of the electroceuticals and digital therapeutics industry, licensing, new health technology assessment, and determination of health insurance fees have emerged as important regulatory issues in Korea. Although various neurotechnology-based medical devices have already been released, research on the latest neurolotechnologies such as BCI is underway, and the regulatory standards for them are unclear, as well as the benefits and risks of the technology. As a result, the need for international standardization and global regulatory harmonization will increase, along with the demand for standardization in technical standards, safety verification, and full cycle risk management. This article deals with the characteristics of medical devices to which the latest neurotechnology is applied, its impact on regulation, and related international discussions, as well as the implications of international standards as soft laws, and reviews international standards for medical devices. Based on these discussions, the trend of international standardization of neurotechnology-based medical devices was reviewed and its implications were derived. In order to resolve the uncertainty of regulations on neurotechnology-based medical devices and to regulate them appropriately, flexible responses are needed on the basis of global regulatory harmonization such as international standardization. Additionally, efforts to preempt international standards in neurotechnology-based medical devices are required because international standards are accepted as domestic norms through national standards and directly affect regulations by individual domestic laws. With the rapid development of BCI technology and technology convergence, related industries will grow further in the future, and international discussions on the regulation of neurotechnology will become more active. Through these international discussions, consideration and regulatory principles for the benefits and risks of neurotechnology should be prepared, and they should be embodied through international standards and domestic norms. In this process, regulatory agencies should lead active participation and cooperation of companies and researchers.

Law Enforcement Role in the Management of Sustainable Natural Resources

This study aims to analyze the role of law enforcement in sustainable natural resource management. By examining the linkages between regulations, legal compliance, and their impact on the environment, this study strives to identify factors that influence the effectiveness of law enforcement and provide urgent recommendations to improve natural resource management practices. The study discusses the challenges, including limited resources and institutional capacity, legal complexity and inconsistency, the importance of support from local communities, and international cooperation in law enforcement. This research, conducted using the literature study method, gathers data and information from various academic sources such as journal articles, books, research reports, and relevant policy documents. The results of the literature research show that law enforcement plays a key role in ensuring the sustainability of natural resource management but is faced with various challenges, such as capacity limitations, corruption, and legal complexity. Community participation proves important in streamlining law enforcement, as policies involving local stakeholders are more likely to be accepted and followed. Better international cooperation and regulatory harmonization are urgently needed to address weaknesses in transnational law enforcement. There is a pressing need to implement a more integrated approach to law enforcement, which includes public education, institutional capacity building, and increased transparency and accountability in law implementation.

Regulatory-approved deep learning/machine learning-based medical devices in Japan as of 2020: A systematic review.

Machine learning (ML) and deep learning (DL) are changing the world and reshaping the medical field. Thus, we conducted a systematic review to determine the status of regulatory-approved ML/DL-based medical devices in Japan, a leading stakeholder in international regulatory harmonization. Information about the medical devices were obtained from the Japan Association for the Advancement of Medical Equipment search service. The usage of ML/DL methodology in the medical devices was confirmed using public announcements or by contacting the marketing authorization holders via e-mail when the public announcements were insufficient for confirmation. Among the 114,150 medical devices found, 11 were regulatory-approved ML/DL-based Software as a Medical Device, with 6 products (54.5%) related to radiology and 5 products (45.5%) related to gastroenterology. The domestic ML/DL-based Software as a Medical Device were mostly related to health check-ups, which are common in Japan. Our review can help understanding the global overview that can foster international competitiveness and further tailored advancements.

Recycling Apparent Waste Into Biologicals: The Case of Umbilical Cord Blood in Italy and Spain.

Most public cord blood banking programs are currently facing financial difficulties due to a progressive decline in the number of cord blood transplants performed worldwide and to a high discard rate of the donated units caused by progressively increasing thresholds of the stem cell dose required to perform safe and effective hemopoietic cord blood transplants. Recycling a proportion of unused cord blood units to prepare novel cord blood components obtained with minimal manipulation (platelets, plasma, red blood cells) and to develop more technologically complex products regulated in the US as Cellular and Gene Therapy Products and in Europe as Advanced Therapy Medicinal Products [e.g. virus-specific T cells (VST), natural killer (NK) cells, induced pluripotent stem cells (iPSCs) is a promising strategy to increase the therapeutic value and reduce the financial deficits of public cord blood banking. Based on encouraging preliminary evidences reported in the literature, additional laboratory studies, large multicenter clinical trials and international regulatory harmonization are necessary to achieve these important goals. This article describes organizational, methodological and regulatory advancements developed in Italy and Spain to promote the clinical use of cord blood platelets, plasma and red blood cells.

Regulatory Cooperation in Securities Market Regulation: Perspectives from Australia

The global financial crisis highlighted the interconnectedness of international financial markets and the risk of contagion it posed. The crisis also emphasized the importance of supranational regulation and regulatory cooperation to address that risk. Yet, although capital flows are global, securities regulation is not. As a 2019 report by IOSCO notes, the regulatory challenges revealed during the global financial crisis have by no means dissipated over the last decade. Lack of international standards, or differences in the way jurisdictions implement such standards, can often result in regulatory-driven market fragmentation. This article considers a range of cooperative techniques designed to achieve international regulatory harmonization and effective cross-border financial market supervision. It discusses three major techniques: (i) transgovernmental networks of financial regulators; (ii) complex multilateral arrangements; and (iii) mutual recognition agreements, and considers the benefits and downsides of each of these regulatory mechanisms. The article focuses particularly on developments in Australia. It examines, for example, a high profile cross-border supervisory experiment, the US-Australian Mutual Recognition Agreement, which the SEC and Australia’s business conduct regulator, ASIC, signed in 2008. This was the first agreement of its kind for the SEC. The article also considers some key regulatory developments in Australia and Asia since the time of the US-Australian Mutual Recognition Agreement.

Regulatory Cooperation in Securities Market Regulation: Perspectives from Australia

The global financial crisis highlighted the interconnectedness of international financial markets and the risk of contagion it posed. The crisis also emphasized the importance of supranational regulation and regulatory cooperation to address that risk. Yet, although capital flows are global, securities regulation is not. As a 2019 report by IOSCO notes, the regulatory challenges revealed during the global financial crisis have by no means dissipated over the last decade. Lack of international standards, or differences in the way jurisdictions implement such standards, can often result in regulatory-driven market fragmentation. This article considers a range of cooperative techniques designed to achieve international regulatory harmonization and effective financial market supervision. It includes discussion of a high profile cross-border supervisory experiment, the 2008 US-Australian Mutual Recognition Agreement, which was the first agreement of its kind for the SEC. The article also examines some key regulatory developments in Australia and Asia since the time of the US-Australian Mutual Recognition Agreement.

The Effect of Regulatory Harmonization on Cross-Border Labor Migration: Evidence from the Accounting Profession

The paper examines whether international regulatory harmonization increases cross-border labor migration. To study this question, we analyze European Union initiatives that harmonized accounting and auditing standards. Regulatory harmonization should reduce economic mobility barriers, essentially making it easier for accounting professionals to move across countries. Our research design compares the cross-border migration of accounting professionals relative to tightly matched other professionals before and after regulatory harmonization. We find that international labor migration in the accounting profession increases significantly relative to other professions. We provide evidence that this effect is due to harmonization, rather than increases in the demand for accounting services during the implementation of the rule changes. The findings illustrate that diversity in rules constitutes an economic barrier to cross-border labor mobility and, more specifically, that accounting harmonization can have a meaningful effect on cross-border migration.

Dilemmas in post-crisis bank regulation: Supranationalization versus retrenchment

The US financial crisis that started in 2007 ultimately had global reach, but those countries most severely affected were the advanced industrialized states. In the United States and Europe, banks, many of which had regional or global profiles, were the source of nearly unprecedented economic instability. This special issue therefore examines the politics behind the re-regulation of banks after the crisis, focusing on the Transatlantic community. The volume finds competing impulses for enhanced international regulatory coordination on the one hand versus national retrenchment on the other. From these two dueling agendas flow three notable developments. First, despite evident functional pressures for a coordinated and global approach to bank regulation following the crisis, regional arrangements have dominated instead. Second, reduced international capital flows and bank activity were as much the result of national and regional regulatory measures as they were a function of market conditions. Third and finally, where national retrenchment has prevailed at the expense of international regulatory harmonization, we see risks for further international financial instability.

The Effect of Regulatory Harmonization on Cross-Border Labor Migration: Evidence from the Accounting Profession

The paper examines whether international regulatory harmonization increases cross-border labor migration. To study this question, we analyze European Union (EU) initiatives that harmonized accounting and auditing standards. Regulatory harmonization should reduce economic mobility barriers, essentially making it easier for accounting professionals to move across countries. Our research design compares the cross-border migration of accounting professionals relative to tightly-matched other professionals before and after regulatory harmonization. We find that international labor migration in the accounting profession increases significantly relative to other professions. We provide evidence that this effect is due to harmonization, rather than increases in the demand for accounting services during the implementation of the rule changes. The findings illustrate that diversity in rules constitutes an economic barrier to cross-border labor mobility and, more specifically, that accounting harmonization can have a meaningful effect on cross-border migration.

Priority review drugs approved by the FDA and the EMA: time for international regulatory harmonization of pharmaceuticals?

The US Food and Drug Administration (FDA) priority review process applies to a drug that is considered a significant improvement over the available alternatives. The European Medicines Agency (EMA) accelerated approval applies to a product that is of major public health interest. This study assessed differences in the characteristics of priority review new molecular entities and new therapeutic biologic products approved by the FDA and the EMA. This study includes regulatory information on drug applications, approvals, indications, and orphan designations of all priority review drugs approved by the FDA and the EMA in the period 1999-2011. Descriptive statistics, t-tests, and chi-squared and Wilcoxon tests were performed. Overall, 100 FDA priority review new molecular entities and new therapeutic biologics were approved by both agencies; 87.0% of the products were first approved by the FDA. The average FDA review time (9.2 ± 8.4 months) was significantly lower than the EMA average review time (14.6 ± 4.0 months) (p < 0.0001). The FDA and the EMA granted orphan designation to 43.0% and 33.0%, respectively, of the applications. There were differences in the administration route (1.0% of all products), dosage (8.0%), strength (23%), posology (51.0%), indications (30.0%), restrictions of use (52.0%), limitations of use (19.0%), and outcomes limitations (28.0%) approved by both regulatory agencies. Significant differences exist in the characteristics of the priority review drugs approved by the FDA and the EMA. Harmonization of the US and European regulatory frameworks may facilitate timely approval of pharmaceutical products.

The Effect of Regulatory Harmonization on Cross-Border Labor Migration: Evidence from the Accounting Profession

The paper examines whether international regulatory harmonization increases cross-border labor migration. To study this question, we analyze European Union (EU) initiatives that harmonized accounting and auditing standards. Regulatory harmonization should reduce economic mobility barriers, essentially making it easier for accounting professionals to move across countries. Our research design compares the cross-border migration of accounting professionals relative to tightly-matched other professionals before and after regulatory harmonization. We find that international labor migration in the accounting profession increases significantly relative to other professions. We provide evidence that this effect is due to harmonization, rather than increases in the demand for accounting services during the implementation of the rule changes. The findings illustrate that diversity in rules constitutes an economic barrier to cross-border labor mobility and, more specifically, that accounting harmonization can have a meaningful effect on cross-border migration.

Regulating Global Capital in the Age of Neoliberalism

Regulating Capital: Setting Standards for the International Financial System. By David Andrew Singer. Ithaca and London: Cornell University Press, 2006. 163 pp., $35.00 (ISBN-13: 978-0-8014-4525-5). David Singer's concise book is about regulators' transnational co-operation and harmonization of financial standards. For Singer, regulators are distinct from lawmakers. He seeks to “demonstrate that regulators themselves are the initiators of harmonization and that elected leaders are important in providing constraints on regulatory policy” (p. 35). Moreover, Singer develops an economistic framework for explaining regulators' specific preferences. There is a trade-off between competitiveness and financial stability. Singer depicts this trade-off and its consequences in a series of standard indifference-curve diagrams. Both stability and relative competitiveness can change, leading to a change in preferences. In general, “a regulator is more likely to seek international regulatory harmonization when its win-set is shrinking due to exogenous shocks” (p. 30). International regulatory harmonization is a way of imposing more stringent regulations for the sake of stability without losing relative competitiveness in global financial markets. The book is well-written and organized, following standard social scientific guidelines. The scene is set—and the need for the book explained—by a brief survey of key historical developments and by a review of the existing literature. The prevailing scholarly opinion tends to see regulatory harmonization as a public good that promotes global financial stability. Singer argues that nearly any standard can be justified as a public good. Yet the regulatory …

Application of the Biopharmaceutical Classification System in Clinical Drug Development—An Industrial View

The biopharmaceutical classification system (BCS) classifies compounds based on their solubility and permeability. Regulatory agencies and health organizations have utilized this classification system to allow dissolution to be used to establish bioequivalence for highly soluble and highly permeable compounds. The pharmaceutical industry has taken advantage of this and BCS-based waivers are becoming more routine and result in significant savings. Further, there is strong scientific rationale to allow BCS-based waivers for even more compounds to realize even more savings. Yet just as clear as the benefits are the barriers that limit application: lack of international regulatory harmonization, uncertainty in regulatory approval, and organizational barriers within the pharmaceutical industry. Once these barriers are overcome and additional applications are fully allowed, the full benefits of BCS applications will be realized.

Explaining cosmetic compliance with international regulatory regimes: The implementation of the Basle Accord in Japan, 1998–2003

A central theme of much recent international political economy (IPE) scholarship has been the question of what determines compliance with international regulatory regimes.1 The contemporary debate ...

How HHS Plans to Move Medical Innovations Forward: Summary of Task Force Report and Recommendations

How HHS Plans to Move Medical Innovations Forward: Summary of Task Force Report and Recommendations

Pharmacopolitics: drug regulation in the United States and Germany

Advocates of rapid access to medicines and critics fearful of inadequate testing both argue that globalization will supersede national medical practices and result in the easy transfer of pharmaceuticals around the world. In Pharmacopolitics, Arthur Daemmrich challenges their assumptions by comparing drug laws, clinical trials, and systems for monitoring adverse reactions in the United States and Germany, two countries with similarly advanced systems for medical research, testing, and patient care. Daemmrich proposes that divergent therapeutic cultures - the interrelationships among governments, patients, the medical profession, and the pharmaceutical industry - underlie national differences and explain variations in pharmaceutical markets and medical care. Daemmrich carries the United States-Germany comparison from 1950 to the present through case studies of Terramycin (an antibiotic), thalidomide (a sedative), propranolol (a heart medication), interleukin-2 (a cancer therapy), and indinavir (an AIDS drug). He points to important differences in government policies and in the distribution of power among key social actors. Daemmrich advises that international regulatory harmonization and globalization in medicine must retain flexibility for social and political variation between countries, even as they achieve technical standardization.

Capital Rules: The Domestic Politics of International Regulatory Harmonization

In the past fifteen years, financial regulators from the developed world have attempted to create international regulatory standards in a variety of financial issue areas. Their negotiations are notable for the stark variation in the preferences of regulators toward international regulatory harmonization. Certain regulators actively resist any attempts at regulatory harmonization, while others are vocal in their advocacy for an international agreement. When will regulators seek to harmonize their rules with their foreign counterparts? I propose a principal-agent framework for analyzing regulator behavior that views international harmonization as a means of satisfying domestic political pressures. The framework predicts that regulators are more likely to seek international regulatory harmonization when confidence in the stability of financial institutions is declining, and when competitive pressures are increasing from foreign firms facing less stringent regulations. I explore the consistency of the framework with two important cases in the history of international financial regulation: the negotiations among bank regulators leading up to the 1988 Basel Accord on bank capital adequacy, and the negotiations among securities regulators over capital adequacy for securities firms between 1988 and 1992.I thank Gabe Aguilera, David Bach, Ethan Bueno de Mesquita, Dan Carpenter, Bill Clark, Mark Copelovitch, Jeff Frieden, Dan Gingerich, Dan Ho, Devesh Kapur, Joseph N. R. Sanberg, Ross Schaap, Allan Stam, Matt Stephenson, two anonymous reviewers, and the editors of IO for helpful comments, discussions, and feedback. I am also indebted to the thirty current and former regulators and financial industry executives who participated in interviews to advance this project. Finally, I thank the Weatherhead Center for International Affairs and the Center for European Studies for research funding.

The International Politics of Harmonization: The Case of Capital Market Regulation

The internationalization and globalization of capital markets greatly complicates the tasks of national financial regulators. It is becoming increasingly difficult, if not impossible, to regulate the activities of banking and securities firms and the broad range of transactions in which they engage on a national level. In this article I explore the process of international regulatory harmonization in capital markets, focusing especially on the mechanisms (political pressure, market pressure, and institutional arrangements) that facilitate this process. I argue that the United States and the United Kingdom are dominant players in the capital market and that the factors most relevant for understanding harmonization processes are (1) whether other jurisdictions have incentives to emulate the regulatory innovations of the dominant financial centers, and (2) whether the dominant centers experience negative externalities in the process. These two factors shed considerable light on whether harmonization will be spurred primarily by market forces or by politics; they also suggest the likely role of international institutions in the process of regulatory harmonization. The argument is illustrated using four issue areas: capital adequacy requirements for banks, anti-money laundering rules, accounting standards, and information sharing among securities regulators.

Business Opportunities and Other Aspects of the Recent International Regulatory Harmonization (&lt;Special Issue&gt;Global Harmonization on Medical Devices)

Business Opportunities and Other Aspects of the Recent International Regulatory Harmonization (&lt;Special Issue&gt;Global Harmonization on Medical Devices)

International Regulatory Status and Harmonization of Food Irradiation

U.S. regulatory officials and some consumer advocates, academicians, media, and industry representatives share the opinion that radiation processing may be a solution to food safety and agricultural protection problems that now exist throughout the world. The status of existing regulations and new regulations being developed by U.S. regulatory agencies and being petitioned by industry groups is discussed and compared with regulations in other countries. Renewed interest on the part of the U.S. Army in using irradiated foods in many of their rations is reviewed. The status of demonstration irradiation facilities sponsored by the Department of Energy is outlined. Comments on harmonization of radiation process controls, dosimetry standards, and other practices that are important aspects of international trade in irradiated foods are provided.