Download or read book Improving Regulation written by Paul S. Fischbeck and published by Routledge. This book was released on 2010-09-30 with total page 480 pages. Available in PDF, EPUB and Kindle. Book excerpt: Is there potential for a U.S. regulatory system that is more efficient and effective? Or is the future likely to involve 'paralysis by analysis'? Improving Regulation considers the challenges faced by the regulatory system as society and technology change, and our knowledge about the effects of our activities on human and planetary health becomes more sophisticated. While considering the difficulty in linking regulatory design and performance, Improving Regulation makes the case for empowering regulatory analysis. Studying applications as diverse as fire protection, air and water pollution, and genetics, its contributors examine the strategies of different stakeholders in today's complex policymaking environment. With a focus on the behavior of institutions and people, they consider the impact that organizational politics, science, technology, and performance have on regulation. They explore the role of technology in creating and reducing uncertainty, the costs of control, the potential involvement of previously unregulated sectors, and the contentious public debates about fairness and participation in regulatory policy. Arguing that the success of many regulations depends upon their acceptance by the public, Fischbeck, Farrow, and their contributors offer extensive, inductive evidence on the art of regulatory analysis. The resulting book provides 'real world' examples of regulation, and a demonstration of how to synthesize analytical skills with a knowledge of physical and social processes.
Download or read book Improving Regulatory Systems written by National Performance Review (U.S.) and published by . This book was released on 1994 with total page 92 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad written by Institute of Medicine and published by National Academies Press. This book was released on 2012-09-03 with total page 366 pages. Available in PDF, EPUB and Kindle. Book excerpt: A very high portion of the seafood we eat comes from abroad, mainly from China and Southeast Asia, and most of the active ingredients in medicines we take originate in other countries. Many low- and middle-income countries have lower labor costs and fewer and less stringent environmental regulations than the United States, making them attractive places to produce food and chemical ingredients for export. Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad explains that the diversity and scale of imports makes it impractical for U.S. Food and Drug Administration (FDA) border inspections to be sufficient to ensure product purity and safety, and incidents such as American deaths due to adulterated heparin imported from China propelled the problem into public awareness. The Institute of Medicine Committee on Strengthening Core Elements of Regulatory Systems in Developing Countries took up the vital task of helping the FDA to cope with the reality that so much of the food, drugs, biologics, and medical products consumed in the United States originate in countries with less-robust regulatory systems. Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad describes the ways the United States can help strengthen regulatory systems in low and middle income countries and promote cross-border partnerships - including government, industry, and academia - to foster regulatory science and build a core of regulatory professionals. This report also emphasizes an array of practical approaches to ensure sound regulatory practices in today's interconnected world.
Download or read book Improving Regulatory Systems written by National Performance Review (U.S.) and published by . This book was released on 1994 with total page 92 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Preparing for Future Products of Biotechnology written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-07-28 with total page 231 pages. Available in PDF, EPUB and Kindle. Book excerpt: Between 1973 and 2016, the ways to manipulate DNA to endow new characteristics in an organism (that is, biotechnology) have advanced, enabling the development of products that were not previously possible. What will the likely future products of biotechnology be over the next 5â€"10 years? What scientific capabilities, tools, and/or expertise may be needed by the regulatory agencies to ensure they make efficient and sound evaluations of the likely future products of biotechnology? Preparing for Future Products of Biotechnology analyzes the future landscape of biotechnology products and seeks to inform forthcoming policy making. This report identifies potential new risks and frameworks for risk assessment and areas in which the risks or lack of risks relating to the products of biotechnology are well understood.
Download or read book Stronger Food and Drug Regulatory Systems Abroad written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2020-04-09 with total page 243 pages. Available in PDF, EPUB and Kindle. Book excerpt: Ensuring the safety of food and the quality and safety of medicines in a country is an important role of government, made more complicated by global manufacturing and international trade. By recent estimates, unsafe food kills over 400,000 people a year, a third of them children under 5, mostly in low- and middle-income countries; every year poor quality medicines cause about 70,000 excess deaths from childhood pneumonia and roughly 8,500 to 20,000 malaria deaths in sub-Saharan Africa alone. The Federal Drug Administration (FDA) Office of Global Policy and Strategy is charged with improving capacity of the agency's foreign counterpart offices and increasing understanding of the importance of regulatory systems for public health, development, and trade. At the request of the FDA, this study sets out a strategy to support good quality, wholesome food and safe, effective medical products around the world. Its goal is to build on the momentum for strengthening regulatory systems and to set a course for sustainability and continued progress. The 2012 report Ensuring Safe Food and Medical Products Through Stronger Regulatory Systems Abroad outlined strategies to secure international supply chains, emphasized capacity building and support for surveillance in low- and middle-income countries, and explored ways to facilitate work sharing among food and medical product regulatory agencies. This new study assess progress made and the current regulatory landscape.
Download or read book Regulating Medicines in a Globalized World written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2020-04-25 with total page 169 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Regulatory System Strengthening in the Americas written by Pan American Health Organization and published by Pan American Health Organization. This book was released on 2021-04-23 with total page 134 pages. Available in PDF, EPUB and Kindle. Book excerpt: Improving access to safe, effective, and quality medicines and other health technologies is a critical public health priority and a fundamental requisite for universal health. National regulatory systems play a key part in a country's health system by overseeing the safety, quality, and efficacy of all health technologies, including pharmaceuticals, vaccines, blood and blood products, and medical devices, among others. The aim of this document is to better understand the regulatory landscape of the Americas, with an emphasis on Latin American National Regulatory Authorities of Reference. This report presents data and analysis corresponding to essential regulatory functions and systems foundations to understand current practices, identify critical issues, and present a series of recommendations for action. The report also includes an overview of the market outlook and economic integration mechanisms in the Americas and their influence on regulatory policy and pharmaceutical trade. In addition, the report includes a supplement to describe salient regulatory emergency responses to the COVID-19 pandemic in the Americas. Through this report, the Pan American Health Organization aims to increase the understanding of national regulatory remits and capacity in the Americas, raise awareness and appreciation of the regional regulatory progress and challenges, identify the regulatory issues emerging markets will bring, and highlight opportunities for evidence-based regulatory system strengthening.
Download or read book Better Regulation Practices across the European Union written by OECD and published by OECD Publishing. This book was released on 2019-03-19 with total page 199 pages. Available in PDF, EPUB and Kindle. Book excerpt: Laws and regulations affect the daily lives of businesses and citizens. High-quality laws promote national welfare and growth, while badly designed laws hinder growth, harm the environment and put the health of citizens at risk. This report analyses practices to improve the quality of laws ...
Download or read book Regulatory Policy and Governance Supporting Economic Growth and Serving the Public Interest written by OECD and published by OECD Publishing. This book was released on 2011-10-25 with total page 155 pages. Available in PDF, EPUB and Kindle. Book excerpt: This report encourages governments to “think big” about the relevance of regulatory policy and assesses the recent efforts of OECD countries to develop and deepen regulatory policy and governance.
Download or read book Economic Regulation and Its Reform written by Nancy L. Rose and published by University of Chicago Press. This book was released on 2014-08-29 with total page 619 pages. Available in PDF, EPUB and Kindle. Book excerpt: The past thirty years have witnessed a transformation of government economic intervention in broad segments of industry throughout the world. Many industries historically subject to economic price and entry controls have been largely deregulated, including natural gas, trucking, airlines, and commercial banking. However, recent concerns about market power in restructured electricity markets, airline industry instability amid chronic financial stress, and the challenges created by the repeal of the Glass-Steagall Act, which allowed commercial banks to participate in investment banking, have led to calls for renewed market intervention. Economic Regulation and Its Reform collects research by a group of distinguished scholars who explore these and other issues surrounding government economic intervention. Determining the consequences of such intervention requires a careful assessment of the costs and benefits of imperfect regulation. Moreover, government interventions may take a variety of forms, from relatively nonintrusive performance-based regulations to more aggressive antitrust and competition policies and barriers to entry. This volume introduces the key issues surrounding economic regulation, provides an assessment of the economic effects of regulatory reforms over the past three decades, and examines how these insights bear on some of today’s most significant concerns in regulatory policy.
Download or read book Pharmaceutical Regulatory Environment written by Reem K. Al-Essa and published by Springer. This book was released on 2015-05-06 with total page 246 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book compares national and centralised procedure practices and key performance metrics, including current approval times, review practices and pharmacovigilance standards, in the seven Gulf States. Opportunities for an improved regulatory system are identified, which, if fully implemented, could have a significant impact on patients’ access to new medicines. The Persian Gulf represents the next growth market for the global biopharmaceutical industry but to date there has been limited information about the regulatory review processes employed in these countries. A thorough examination of the strategies currently being implemented by the Gulf States is considered critical to the future regulatory environment in this region. Pharmaceutical Regulatory Environment: Challenges & Opportunities in the Gulf Region is a must read for those interested in pharmaceutical regulation in the Gulf region.
Download or read book Regulation written by Jerry Brito and published by Mercatus Center at George Mason University. This book was released on 2012-08-13 with total page 128 pages. Available in PDF, EPUB and Kindle. Book excerpt: Federal regulations affect nearly every area of our lives and interest in them is increasing. However, many people have no idea how regulations are developed or how they have an impact on our lives. Regulation: A Primer by Susan Dudley and Jerry Brito provides an accessible overview of regulatory theory, analysis, and practice. The Primer examines the constitutional underpinnings of federal regulation and discusses who writes and enforces regulation and how they do it. Published by the Mercatus Center at George Mason University, it also provides insights into the different varieties of regulation and how to analyze whether a regulatory proposal makes citizens better or worse off. Each chapter discusses key aspects of regulation and provides further readings for those interested in exploring these topics in more detail.
Download or read book Food control system assessment tool Introduction and glossary written by Food and Agriculture Organization of the United Nations and published by Food & Agriculture Org.. This book was released on 2019-07-09 with total page 44 pages. Available in PDF, EPUB and Kindle. Book excerpt: The main objective of the tool is to propose a harmonized, objective and consensual basis to analyse the performance of a national food control system. It is intended to be used by countries as a supporting basis for self-assessment to identify priority areas of improvement and plan sequential and coordinated activities to reach expected outcomes, and by repeating the assessment on a regular basis, countries can monitor their progresses. The Tool is based on Codex principles and Guidelines for National Food Control Systems as well as other relevant Codex guidance for food control systems, which are referenced throughout the document. Its scope is given by the dual objectives quoted in Codex guidance for these systems: protect health of consumers and ensure fair practices in the food trade. This introductory volume presents the FAO/WHO Food Control System Assessment Tool, providing background to its development and outlining its main scope and objectives. It presents a thorough review of the assessment Tool structure, breaking it down into its constitutive elements (dimensions, sub-dimensions, competencies and assessment criteria). Finally, it gives an overview of the assessment approach, from the ratings to the descriptive analysis supporting the allocation of scores. The volume also contains a glossary of useful terms and the list of Codex documents referenced in the Tool.
Download or read book Special Report on Regulatory Reform written by United States. Congressional Oversight Panel and published by . This book was released on 2009 with total page 109 pages. Available in PDF, EPUB and Kindle. Book excerpt: Modern financial regulation can provide consumers and investors with adequate information for making sound financial decisions and can protect them from being misled or defrauded, especially in complex financial transactions. Better regulation can reduce conflicts of interest and help manage moral hazard, particularly by limiting incentives for excessive risk taking stemming from often implicit government guaranties. By limiting risk taking in key parts of the financial sector, regulation can reduce systemic threats to the broader financial system and the economy as a whole. Ultimately, financial regulation embodies good risk management, transparency, and fairness.
Download or read book Achieving Regulatory Excellence written by Cary Coglianese and published by Brookings Institution Press. This book was released on 2016-12-20 with total page 360 pages. Available in PDF, EPUB and Kindle. Book excerpt: Whether striving to protect citizens from financial risks, climate change, inadequate health care, or the uncertainties of the emerging “sharing” economy, regulators must routinely make difficult judgment calls in an effort to meet the conflicting demands that society places on them. Operating within a political climate of competing demands, regulators need a lodestar to help them define and evaluate success. Achieving Regulatory Excellence provides that direction by offering new insights from law, public administration, political science, sociology, and policy sciences on what regulators need to do to improve their performance. Achieving Regulatory Excellence offers guidance from leading international experts about how regulators can set appropriate priorities and make sound, evidence-based decisions through processes that are transparent and participatory. With increasing demands for smarter but leaner government, the need for sound regulatory capacity—for regulatory excellence—has never been stronger.
Download or read book Macondo Well Deepwater Horizon Blowout written by National Research Council and published by National Academies Press. This book was released on 2012-03-02 with total page 236 pages. Available in PDF, EPUB and Kindle. Book excerpt: The blowout of the Macondo well on April 20, 2010, led to enormous consequences for the individuals involved in the drilling operations, and for their families. Eleven workers on the Deepwater Horizon drilling rig lost their lives and 16 others were seriously injured. There were also enormous consequences for the companies involved in the drilling operations, to the Gulf of Mexico environment, and to the economy of the region and beyond. The flow continued for nearly 3 months before the well could be completely killed, during which time, nearly 5 million barrels of oil spilled into the gulf. Macondo Well-Deepwater Horizon Blowout examines the causes of the blowout and provides a series of recommendations, for both the oil and gas industry and government regulators, intended to reduce the likelihood and impact of any future losses of well control during offshore drilling. According to this report, companies involved in offshore drilling should take a "system safety" approach to anticipating and managing possible dangers at every level of operation-from ensuring the integrity of wells to designing blowout preventers that function under all foreseeable conditions-in order to reduce the risk of another accident as catastrophic as the Deepwater Horizon explosion and oil spill. In addition, an enhanced regulatory approach should combine strong industry safety goals with mandatory oversight at critical points during drilling operations. Macondo Well-Deepwater Horizon Blowout discusses ultimate responsibility and accountability for well integrity and safety of offshore equipment, formal system safety education and training of personnel engaged in offshore drilling, and guidelines that should be established so that well designs incorporate protection against the various credible risks associated with the drilling and abandonment process. This book will be of interest to professionals in the oil and gas industry, government decision makers, environmental advocacy groups, and others who seek an understanding of the processes involved in order to ensure safety in undertakings of this nature.
