Ensuring Safe Foods And Medical Products Through Stronger Regulatory Systems Abroad
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Ensuring Safe Foods And Medical Products Through Stronger Regulatory Systems Abroad
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2012-09-03
Ensuring Safe Foods And Medical Products Through Stronger Regulatory Systems Abroad written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-09-03 with Medical categories.
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.
Ensuring Safe Foods And Medical Products Through Stronger Regulatory Systems Abroad
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Author : Jim E. Riviere
language : en
Publisher:
Release Date : 1900
Ensuring Safe Foods And Medical Products Through Stronger Regulatory Systems Abroad written by Jim E. Riviere and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1900 with Food industry and trade categories.
Stronger Food And Drug Regulatory Systems Abroad
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Author : National Academies of Sciences, Engineering, and Medicine
language : en
Publisher: National Academies Press
Release Date : 2020-04-09
Stronger Food And Drug Regulatory Systems Abroad written by National Academies of Sciences, Engineering, and Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-04-09 with Medical categories.
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.
Food And Drug Administration Fda
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Author : Marcia Crosse
language : en
Publisher: DIANE Publishing
Release Date : 2011-05
Food And Drug Administration Fda written by Marcia Crosse and has been published by DIANE Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-05 with Reference categories.
An increasing volume of food and medical products marketed in the U.S. are produced in foreign countries. This globalization has challenged the FDA, which is responsible for ensuring the safety of these products. In late 2008 and early 2009, FDA established overseas offices comprised of 42 total staff covering particular countries or regions. The offices develop info. that FDA officials can use to make better decisions about products manufactured in foreign countries, among other activities. This report examined: (1) the steps overseas offices have taken to help ensure the safety of imported products; and (2) the extent to which FDA has engaged in long-term strategic and workforce planning for the overseas offices. Charts and tables. A print on demand report.
Stronger Food And Drug Regulatory Systems Abroad
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Author : National Academies of Sciences, Engineering, and Medicine
language : en
Publisher: National Academies Press
Release Date : 2020-03-09
Stronger Food And Drug Regulatory Systems Abroad written by National Academies of Sciences, Engineering, and Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-03-09 with Medical categories.
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.
Ensuring Safe Food
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Author : Committee to Ensure Safe Food from Production to Consumption
language : en
Publisher: National Academies Press
Release Date : 1998-09-02
Ensuring Safe Food written by Committee to Ensure Safe Food from Production to Consumption and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 1998-09-02 with Medical categories.
How safe is our food supply? Each year the media report what appears to be growing concern related to illness caused by the food consumed by Americans. These food borne illnesses are caused by pathogenic microorganisms, pesticide residues, and food additives. Recent actions taken at the federal, state, and local levels in response to the increase in reported incidences of food borne illnesses point to the need to evaluate the food safety system in the United States. This book assesses the effectiveness of the current food safety system and provides recommendations on changes needed to ensure an effective science-based food safety system. Ensuring Safe Food discusses such important issues as: What are the primary hazards associated with the food supply? What gaps exist in the current system for ensuring a safe food supply? What effects do trends in food consumption have on food safety? What is the impact of food preparation and handling practices in the home, in food services, or in production operations on the risk of food borne illnesses? What organizational changes in responsibility or oversight could be made to increase the effectiveness of the food safety system in the United States? Current concerns associated with microbiological, chemical, and physical hazards in the food supply are discussed. The book also considers how changes in technology and food processing might introduce new risks. Recommendations are made on steps for developing a coordinated, unified system for food safety. The book also highlights areas that need additional study. Ensuring Safe Food will be important for policymakers, food trade professionals, food producers, food processors, food researchers, public health professionals, and consumers.
Regulating Medicines In A Globalized World
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Author : National Academies of Sciences, Engineering, and Medicine
language : en
Publisher: National Academies Press
Release Date : 2020-04-25
Regulating Medicines In A Globalized World written by National Academies of Sciences, Engineering, and Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-04-25 with Medical categories.
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.
Trade And Food Standards
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Author : Food and Agriculture Organization of the United Nations
language : en
Publisher: Food & Agriculture Org.
Release Date : 2018-05-25
Trade And Food Standards written by Food and Agriculture Organization of the United Nations and has been published by Food & Agriculture Org. this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-05-25 with Political Science categories.
This publication emphasizes the importance of participation and engagement of governments in standards development in Codex and in resolving trade concerns in the WTO SPS and TBT Committees, as well as the importance of capacity development, which together contribute to the dynamism and robustness of the global system of food standards and trade.
Counterfeit Drugs
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Author : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Oversight and Investigations
language : en
Publisher:
Release Date : 2015
Counterfeit Drugs written by United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Oversight and Investigations and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015 with Consumer protection categories.
International Regulatory Harmonization Amid Globalization Of Drug Development
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2013-11-24
International Regulatory Harmonization Amid Globalization Of Drug Development written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-11-24 with Medical categories.
The past several decades have been a time of rapid globalization in the development, manufacture, marketing, and distribution of medical products and technologies. Increasingly, research on the safety and effectiveness of new drugs is being conducted in countries with little experience in regulation of medical product development. Demand has been increasing for globally harmonized, science-based standards for the development and evaluation of the safety, quality, and efficacy of medical products. Consistency of such standards could improve the efficiency and clarity of the drug development and evaluation process and, ultimately, promote and enhance product quality and the public health. To explore the need and prospects for greater international regulatory harmonization for drug development, the IOM Forum on Drug Discovery, Development, and Translation hosted a workshop on February 13-14, 2013. Discussions at the workshop helped identify principles, potential approaches, and strategies to advance the development or evolution of more harmonized regulatory standards. This document summarizes the workshop.