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Stronger Food And Drug Regulatory Systems Abroad
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Author :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :0309670438 Total Pages :243 pages Book Rating :4.3/5 (96 download)
Book Synopsis Stronger Food and Drug Regulatory Systems Abroad by : National Academies of Sciences, Engineering, and Medicine
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.
Book Synopsis Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad by : Institute of Medicine
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.
Book Synopsis Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad by : Jim E. Riviere
Download or read book Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad written by Jim E. Riviere and published by . This book was released on 1900 with total page 366 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Countering the Problem of Falsified and Substandard Drugs by : Institute of Medicine
Download or read book Countering the Problem of Falsified and Substandard Drugs written by Institute of Medicine and published by National Academies Press. This book was released on 2013-06-20 with total page 377 pages. Available in PDF, EPUB and Kindle. Book excerpt: The adulteration and fraudulent manufacture of medicines is an old problem, vastly aggravated by modern manufacturing and trade. In the last decade, impotent antimicrobial drugs have compromised the treatment of many deadly diseases in poor countries. More recently, negligent production at a Massachusetts compounding pharmacy sickened hundreds of Americans. While the national drugs regulatory authority (hereafter, the regulatory authority) is responsible for the safety of a country's drug supply, no single country can entirely guarantee this today. The once common use of the term counterfeit to describe any drug that is not what it claims to be is at the heart of the argument. In a narrow, legal sense a counterfeit drug is one that infringes on a registered trademark. The lay meaning is much broader, including any drug made with intentional deceit. Some generic drug companies and civil society groups object to calling bad medicines counterfeit, seeing it as the deliberate conflation of public health and intellectual property concerns. Countering the Problem of Falsified and Substandard Drugs accepts the narrow meaning of counterfeit, and, because the nuances of trademark infringement must be dealt with by courts, case by case, the report does not discuss the problem of counterfeit medicines.
Book Synopsis Enhancing Food Safety by : National Research Council
Download or read book Enhancing Food Safety written by National Research Council and published by National Academies Press. This book was released on 2010-11-04 with total page 589 pages. Available in PDF, EPUB and Kindle. Book excerpt: Recent outbreaks of illnesses traced to contaminated sprouts and lettuce illustrate the holes that exist in the system for monitoring problems and preventing foodborne diseases. Although it is not solely responsible for ensuring the safety of the nation's food supply, the U.S. Food and Drug Administration (FDA) oversees monitoring and intervention for 80 percent of the food supply. The U.S. Food and Drug Administration's abilities to discover potential threats to food safety and prevent outbreaks of foodborne illness are hampered by impediments to efficient use of its limited resources and a piecemeal approach to gathering and using information on risks. Enhancing Food Safety: The Role of the Food and Drug Administration, a new book from the Institute of Medicine and the National Research Council, responds to a congressional request for recommendations on how to close gaps in FDA's food safety systems. Enhancing Food Safety begins with a brief review of the Food Protection Plan (FPP), FDA's food safety philosophy developed in 2007. The lack of sufficient detail and specific strategies in the FPP renders it ineffectual. The book stresses the need for FPP to evolve and be supported by the type of strategic planning described in these pages. It also explores the development and implementation of a stronger, more effective food safety system built on a risk-based approach to food safety management. Conclusions and recommendations include adopting a risk-based decision-making approach to food safety; creating a data surveillance and research infrastructure; integrating federal, state, and local government food safety programs; enhancing efficiency of inspections; and more. Although food safety is the responsibility of everyone, from producers to consumers, the FDA and other regulatory agencies have an essential role. In many instances, the FDA must carry out this responsibility against a backdrop of multiple stakeholder interests, inadequate resources, and competing priorities. Of interest to the food production industry, consumer advocacy groups, health care professionals, and others, Enhancing Food Safety provides the FDA and Congress with a course of action that will enable the agency to become more efficient and effective in carrying out its food safety mission in a rapidly changing world.
Author :Food and Agriculture Organization of the United Nations Publisher :Food & Agriculture Org. ISBN 13 :9251316309 Total Pages :44 pages Book Rating :4.2/5 (513 download)
Book Synopsis Food control system assessment tool: Introduction and glossary by : Food and Agriculture Organization of the United Nations
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.
Author :Committee to Ensure Safe Food from Production to Consumption Publisher :National Academies Press ISBN 13 :0309593409 Total Pages :209 pages Book Rating :4.3/5 (95 download)
Book Synopsis Ensuring Safe Food by : Committee to Ensure Safe Food from Production to Consumption
Download or read book Ensuring Safe Food written by Committee to Ensure Safe Food from Production to Consumption and published by National Academies Press. This book was released on 1998-09-02 with total page 209 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis The Use of Drugs in Food Animals by : National Research Council
Download or read book The Use of Drugs in Food Animals written by National Research Council and published by National Academies Press. This book was released on 1999-01-12 with total page 276 pages. Available in PDF, EPUB and Kindle. Book excerpt: The use of drugs in food animal production has resulted in benefits throughout the food industry; however, their use has also raised public health safety concerns. The Use of Drugs in Food Animals provides an overview of why and how drugs are used in the major food-producing animal industriesâ€"poultry, dairy, beef, swine, and aquaculture. The volume discusses the prevalence of human pathogens in foods of animal origin. It also addresses the transfer of resistance in animal microbes to human pathogens and the resulting risk of human disease. The committee offers analysis and insight into these areas: Monitoring of drug residues. The book provides a brief overview of how the FDA and USDA monitor drug residues in foods of animal origin and describes quality assurance programs initiated by the poultry, dairy, beef, and swine industries. Antibiotic resistance. The committee reports what is known about this controversial problem and its potential effect on human health. The volume also looks at how drug use may be minimized with new approaches in genetics, nutrition, and animal management.
Book Synopsis The Safe Food Imperative by : Steven Jaffee
Download or read book The Safe Food Imperative written by Steven Jaffee and published by World Bank Publications. This book was released on 2018-12-11 with total page 208 pages. Available in PDF, EPUB and Kindle. Book excerpt: This report strengthens the economic case for increased public investment and more robust policy attention to food safety in low and middle income countries and provides guidance on ways to achieve significant, broad-based impact from such actions.
Author :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :0309452058 Total Pages :231 pages Book Rating :4.3/5 (94 download)
Book Synopsis Preparing for Future Products of Biotechnology by : National Academies of Sciences, Engineering, and Medicine
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.
Author :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :0309498511 Total Pages :103 pages Book Rating :4.3/5 (94 download)
Book Synopsis The Role of NIH in Drug Development Innovation and Its Impact on Patient Access by : National Academies of Sciences, Engineering, and Medicine
Download or read book The Role of NIH in Drug Development Innovation and Its Impact on Patient Access written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2020-01-27 with total page 103 pages. Available in PDF, EPUB and Kindle. Book excerpt: To explore the role of the National Institutes of Health (NIH) in innovative drug development and its impact on patient access, the Board on Health Care Services and the Board on Health Sciences Policy of the National Academies jointly hosted a public workshop on July 24â€"25, 2019, in Washington, DC. Workshop speakers and participants discussed the ways in which federal investments in biomedical research are translated into innovative therapies and considered approaches to ensure that the public has affordable access to the resulting new drugs. This publication summarizes the presentations and discussions from the workshop.
Book Synopsis Modern Methods of Clinical Investigation by : Institute of Medicine
Download or read book Modern Methods of Clinical Investigation written by Institute of Medicine and published by National Academies Press. This book was released on 1990-02-01 with total page 241 pages. Available in PDF, EPUB and Kindle. Book excerpt: The very rapid pace of advances in biomedical research promises us a wide range of new drugs, medical devices, and clinical procedures. The extent to which these discoveries will benefit the public, however, depends in large part on the methods we choose for developing and testing them. Modern Methods of Clinical Investigation focuses on strategies for clinical evaluation and their role in uncovering the actual benefits and risks of medical innovation. Essays explore differences in our current systems for evaluating drugs, medical devices, and clinical procedures; health insurance databases as a tool for assessing treatment outcomes; the role of the medical profession, the Food and Drug Administration, and industry in stimulating the use of evaluative methods; and more. This book will be of special interest to policymakers, regulators, executives in the medical industry, clinical researchers, and physicians.
Author :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :0309494834 Total Pages :125 pages Book Rating :4.3/5 (94 download)
Book Synopsis Value Proposition and Innovative Models for Multi-Sectoral Engagement in Global Health by : National Academies of Sciences, Engineering, and Medicine
Download or read book Value Proposition and Innovative Models for Multi-Sectoral Engagement in Global Health written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2020-04-17 with total page 125 pages. Available in PDF, EPUB and Kindle. Book excerpt: To explore value proposition for different sectors that engage in global health - including industry, government, philanthropy, and civil society - and innovative models for multi-sectoral collaboration, the Forum on Public-Private Partnerships for Global Health and Safety of the National Academies of Sciences, Engineering, and Medicine convened a 2-day workshop on November 15 and 16, 2018. With a specific focus on industry engagement, the workshop examined how stakeholders within industry define and measure value relative to global health as well as how and why other sectors in the global health community engage with industry. This publication summarizes the presentation and discussion of the workshop.
Author :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :0309498635 Total Pages :169 pages Book Rating :4.3/5 (94 download)
Book Synopsis Regulating Medicines in a Globalized World by : National Academies of Sciences, Engineering, and Medicine
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.
Book Synopsis Regulatory Affairs in the Pharmaceutical Industry by : Javed Ali
Download or read book Regulatory Affairs in the Pharmaceutical Industry written by Javed Ali and published by Academic Press. This book was released on 2021-11-14 with total page 287 pages. Available in PDF, EPUB and Kindle. Book excerpt: Regulatory Affairs in the Pharmaceutical Industry is a comprehensive reference that compiles all the information available pertaining to regulatory procedures currently followed by the pharmaceutical industry. Designed to impart advanced knowledge and skills required to learn the various concepts of regulatory affairs, the content covers new drugs, generic drugs and their development, regulatory filings in different countries, different phases of clinical trials, and the submission of regulatory documents like IND (Investigational New Drug), NDA (New Drug Application) and ANDA (Abbreviated New Drug Application). Chapters cover documentation in the pharmaceutical industry, generic drug development, code of Federal Regulation (CFR), the ANDA regulatory approval process, the process and documentation for US registration of foreign drugs, the regulation of combination products and medical devices, the CTD and ECTD formats, and much more. Updated reference on drug approval processes in key global markets Provides comprehensive coverage of concepts and regulatory affairs Presents a concise compilation of the regulatory requirements of different countries Introduces the fundamentals of manufacturing controls and their regulatory importance
Author :FAO/WHO Publisher :Food and Agriculture Organization of the United Nations ISBN 13 :9251323402 Total Pages :112 pages Book Rating :4.2/5 (513 download)
Book Synopsis The future of food safety by : FAO/WHO
Download or read book The future of food safety written by FAO/WHO and published by Food and Agriculture Organization of the United Nations. This book was released on 2020-06-01 with total page 112 pages. Available in PDF, EPUB and Kindle. Book excerpt: This technical summary prepared by FAO and the World Health Organization (WHO) reports on the two international food safety conferences held in Addis Ababa and Geneva in February and April 2019. It recalls the key actions and strategies presented to address current and future challenges to food safety globally and the steps required to strengthen commitment at the highest political level to scale up food safety in the 2030 Agenda for Sustainable Development. At a pivotal moment focussing international attention on actions needed to bolster food safety, this publication recalls the priorities discussed so that food safety strategies and approaches can be aligned across sectors and borders, reinforcing efforts to reach the Sustainable Development Goals and supporting the UN Decade of Action on Nutrition.
Book Synopsis International Health Regulations (2005) by : World Health Organization
Download or read book International Health Regulations (2005) written by World Health Organization and published by World Health Organization. This book was released on 2008-12-15 with total page 82 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
