Regulation Of Pharmaceuticals In Developing Countries

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Regulating Medicines in a Globalized World

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)

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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.

Intellectual Property, Pharmaceuticals and Public Health

Author : Kenneth C. Shadlen
Publisher : Edward Elgar Publishing
ISBN 13 : 0857938614
Total Pages : 353 pages
Book Rating : 4.8/5 (579 download)

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Book Synopsis Intellectual Property, Pharmaceuticals and Public Health by : Kenneth C. Shadlen

Download or read book Intellectual Property, Pharmaceuticals and Public Health written by Kenneth C. Shadlen and published by Edward Elgar Publishing. This book was released on 2011-01-01 with total page 353 pages. Available in PDF, EPUB and Kindle. Book excerpt: 'This impressive collection offers fascinating new perspectives on the impact of pharmaceutical patents on access to medicines in developing countries. The volume's editors have put together an important book that sets out clearly the challenges to public health in a wide range of national contexts. The book will be a valuable text for all scholars and decision-makers interested in the global politics of intellectual property rights and public health.' – Duncan Matthews, Queen Mary, University of London, UK This up-to-date book examines pharmaceutical development, access to medicines, and the protection of public health in the context of two fundamental changes that the global political economy has undergone since the 1970s, the globalization of trade and production and the increased harmonization of national regulations on intellectual property rights. With authors from eleven different countries presenting case studies of national experiences in Africa, Asia and the Americas, the book analyzes national strategies to promote pharmaceutical innovation, while at the same time assuring widespread access to medicines through generic pharmaceutical production and generic pharmaceutical importation. The expert chapters focus on patents as well as an array of regulatory instruments, including pricing and drug registration policies. Presenting in-depth analysis and original empirical research, this book will strongly appeal to academics and students of intellectual property, international health, international political economy, international development and law.

Disease Control Priorities in Developing Countries

Author : Dean T. Jamison
Publisher : World Bank Publications
ISBN 13 : 0821361805
Total Pages : 1449 pages
Book Rating : 4.8/5 (213 download)

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Book Synopsis Disease Control Priorities in Developing Countries by : Dean T. Jamison

Download or read book Disease Control Priorities in Developing Countries written by Dean T. Jamison and published by World Bank Publications. This book was released on 2006-04-02 with total page 1449 pages. Available in PDF, EPUB and Kindle. Book excerpt: Based on careful analysis of burden of disease and the costs ofinterventions, this second edition of 'Disease Control Priorities in Developing Countries, 2nd edition' highlights achievable priorities; measures progresstoward providing efficient, equitable care; promotes cost-effectiveinterventions to targeted populations; and encourages integrated effortsto optimize health. Nearly 500 experts - scientists, epidemiologists, health economists,academicians, and public health practitioners - from around the worldcontributed to the data sources and methodologies, and identifiedchallenges and priorities, resulting in this integrated, comprehensivereference volume on the state of health in developing countries.

Pharmaceutical Medicine and Translational Clinical Research

Author : Divya Vohora
Publisher : Academic Press
ISBN 13 : 0128020989
Total Pages : 527 pages
Book Rating : 4.1/5 (28 download)

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Book Synopsis Pharmaceutical Medicine and Translational Clinical Research by : Divya Vohora

Download or read book Pharmaceutical Medicine and Translational Clinical Research written by Divya Vohora and published by Academic Press. This book was released on 2017-11-14 with total page 527 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical Medicine and Translational Clinical Research covers clinical testing of medicines and the translation of pharmaceutical drug research into new medicines, also focusing on the need to understand the safety profile of medicine and the benefit-risk balance. Pharmacoeconomics and the social impact of healthcare on patients and public health are also featured. It is written in a clear and straightforward manner to enable rapid review and assimilation of complex information and contains reader-friendly features.As a greater understanding of these aspects is critical for students in the areas of pharmaceutical medicine, clinical research, pharmacology and pharmacy, as well as professionals working in the pharmaceutical industry, this book is an ideal resource. - Includes detailed coverage of current trends and key topics in pharmaceutical medicine, including biosimilars, biobetters, super generics, and - Provides a comprehensive look at current and important aspects of the science and regulation of drug and biologics discovery

Regulatory Affairs in the Pharmaceutical Industry

Author : Javed Ali
Publisher : Academic Press
ISBN 13 : 0128222239
Total Pages : 287 pages
Book Rating : 4.1/5 (282 download)

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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

The Changing Economics of Medical Technology

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 030904491X
Total Pages : 225 pages
Book Rating : 4.3/5 (9 download)

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Book Synopsis The Changing Economics of Medical Technology by : Institute of Medicine

Download or read book The Changing Economics of Medical Technology written by Institute of Medicine and published by National Academies Press. This book was released on 1991-02-01 with total page 225 pages. Available in PDF, EPUB and Kindle. Book excerpt: Americans praise medical technology for saving lives and improving health. Yet, new technology is often cited as a key factor in skyrocketing medical costs. This volume, second in the Medical Innovation at the Crossroads series, examines how economic incentives for innovation are changing and what that means for the future of health care. Up-to-date with a wide variety of examples and case studies, this book explores how payment, patent, and regulatory policiesâ€"as well as the involvement of numerous government agenciesâ€"affect the introduction and use of new pharmaceuticals, medical devices, and surgical procedures. The volume also includes detailed comparisons of policies and patterns of technological innovation in Western Europe and Japan. This fact-filled and practical book will be of interest to economists, policymakers, health administrators, health care practitioners, and the concerned public.

WHO guideline on country pharmaceutical pricing policies

Author :
Publisher : World Health Organization
ISBN 13 : 9240011870
Total Pages : 70 pages
Book Rating : 4.2/5 (4 download)

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Book Synopsis WHO guideline on country pharmaceutical pricing policies by :

Download or read book WHO guideline on country pharmaceutical pricing policies written by and published by World Health Organization. This book was released on 2020-09-29 with total page 70 pages. Available in PDF, EPUB and Kindle. Book excerpt: In recent years, high prices of pharmaceutical products have posed challenges in high- and low-income countries alike. In many instances, high prices of pharmaceutical products have led to significant financial hardship for individuals and negatively impacted on healthcare systems' ability to provide population-wide access to essential medicines. Pharmaceutical pricing policies need to be carefully planned, carried out, and regularly checked and revised according to changing conditions. Strong, well-thought-out policies can guide well-informed and balanced decisions to achieve affordable access to essential health products. This guideline replaces the 2015 WHO guideline on country pharmaceutical pricing policies, revised to reflect the growing body of literature since the last evidence review in 2010. This update also recognizes country experiences in managing the prices of pharmaceutical products.

Rare Diseases and Orphan Products

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309158060
Total Pages : 442 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Rare Diseases and Orphan Products by : Institute of Medicine

Download or read book Rare Diseases and Orphan Products written by Institute of Medicine and published by National Academies Press. This book was released on 2011-04-03 with total page 442 pages. Available in PDF, EPUB and Kindle. Book excerpt: Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.

A Practical Approach to Pharmaceutical Policy

Author : Andreas Seiter
Publisher : World Bank Publications
ISBN 13 : 0821383876
Total Pages : 240 pages
Book Rating : 4.8/5 (213 download)

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Book Synopsis A Practical Approach to Pharmaceutical Policy by : Andreas Seiter

Download or read book A Practical Approach to Pharmaceutical Policy written by Andreas Seiter and published by World Bank Publications. This book was released on 2010-06-17 with total page 240 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book offers policy makers a hands-on approach, tested in the World Bank’s field work in many countries, for developing policies that improve access to safe, effective medicines in health systems of low- and middle-income economies.

Making Medicines Affordable

Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 0309468086
Total Pages : 235 pages
Book Rating : 4.3/5 (94 download)

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Book Synopsis Making Medicines Affordable by : National Academies of Sciences, Engineering, and Medicine

Download or read book Making Medicines Affordable written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2018-03-01 with total page 235 pages. Available in PDF, EPUB and Kindle. Book excerpt: Thanks to remarkable advances in modern health care attributable to science, engineering, and medicine, it is now possible to cure or manage illnesses that were long deemed untreatable. At the same time, however, the United States is facing the vexing challenge of a seemingly uncontrolled rise in the cost of health care. Total medical expenditures are rapidly approaching 20 percent of the gross domestic product and are crowding out other priorities of national importance. The use of increasingly expensive prescription drugs is a significant part of this problem, making the cost of biopharmaceuticals a serious national concern with broad political implications. Especially with the highly visible and very large price increases for prescription drugs that have occurred in recent years, finding a way to make prescription medicinesâ€"and health care at largeâ€"more affordable for everyone has become a socioeconomic imperative. Affordability is a complex function of factors, including not just the prices of the drugs themselves, but also the details of an individual's insurance coverage and the number of medical conditions that an individual or family confronts. Therefore, any solution to the affordability issue will require considering all of these factors together. The current high and increasing costs of prescription drugsâ€"coupled with the broader trends in overall health care costsâ€"is unsustainable to society as a whole. Making Medicines Affordable examines patient access to affordable and effective therapies, with emphasis on drug pricing, inflation in the cost of drugs, and insurance design. This report explores structural and policy factors influencing drug pricing, drug access programs, the emerging role of comparative effectiveness assessments in payment policies, changing finances of medical practice with regard to drug costs and reimbursement, and measures to prevent drug shortages and foster continued innovation in drug development. It makes recommendations for policy actions that could address drug price trends, improve patient access to affordable and effective treatments, and encourage innovations that address significant needs in health care.

International Cooperation, Convergence and Harmonization of Pharmaceutical Regulations

Author : Pierre-Louis Lezotre
Publisher : Academic Press
ISBN 13 : 0128005696
Total Pages : 377 pages
Book Rating : 4.1/5 (28 download)

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Book Synopsis International Cooperation, Convergence and Harmonization of Pharmaceutical Regulations by : Pierre-Louis Lezotre

Download or read book International Cooperation, Convergence and Harmonization of Pharmaceutical Regulations written by Pierre-Louis Lezotre and published by Academic Press. This book was released on 2013-12-05 with total page 377 pages. Available in PDF, EPUB and Kindle. Book excerpt: International Cooperation, Convergence and Harmonization of Pharmaceutical Regulations: A Global Perspective provides the current status of the complex and broad phenomenon of cooperation, convergence and harmonization in the pharmaceutical sector (Part I), thoroughly evaluates its added value and its critical parameters and influencing factors (Part II) in order to recommend actions and measures to support the next steps for cooperation, convergence and harmonization (Part III). All of these recommendations in the book support the establishment of a better coordinated global pharmaceutical system which represents the best realistic alternative to fulfill the objective to establish a global coalition of regulators and to respond to an increased demand to further cooperation in the pharmaceutical sector. This proposed framework, which leverages all of the ongoing positive cooperation initiatives and uses as foundations all of the numerous harmonization projects developed over the years, presents advantages for all stakeholders and would definitively have significant added value to the promotion and protection of global public health. The status of all major worldwide harmonization and cooperation initiatives (at bilateral, regional, and global levels) The value of cooperation in the pharmaceutical sector and the driving factors behind harmonization The proposition of a structure for the global pharmaceutical system and timely recommendations for enhancing international cooperation, as well as further discussion and policy changes in this area

How to Develop and Implement a National Drug Policy

Author : World Health Organization
Publisher : World Health Organization
ISBN 13 : 9789241545471
Total Pages : 104 pages
Book Rating : 4.5/5 (454 download)

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Book Synopsis How to Develop and Implement a National Drug Policy by : World Health Organization

Download or read book How to Develop and Implement a National Drug Policy written by World Health Organization and published by World Health Organization. This book was released on 2001 with total page 104 pages. Available in PDF, EPUB and Kindle. Book excerpt: A drug policy is a crucial ingredient in every country's national health strategy as it provides a strategic framework to identify goals and commitments. This publication discusses the key components of such a policy. Issues covered include: the selection of essential drugs, affordability; finance and supply; regulation and quality assurance; rational use; research; human resources; monitoring and evaluation.

Encyclopedia of Health Economics

Author :
Publisher : Newnes
ISBN 13 : 0123756790
Total Pages : 1663 pages
Book Rating : 4.1/5 (237 download)

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Book Synopsis Encyclopedia of Health Economics by :

Download or read book Encyclopedia of Health Economics written by and published by Newnes. This book was released on 2014-02-21 with total page 1663 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Encyclopedia of Health Economics offers students, researchers and policymakers objective and detailed empirical analysis and clear reviews of current theories and polices. It helps practitioners such as health care managers and planners by providing accessible overviews into the broad field of health economics, including the economics of designing health service finance and delivery and the economics of public and population health. This encyclopedia provides an organized overview of this diverse field, providing one trusted source for up-to-date research and analysis of this highly charged and fast-moving subject area. Features research-driven articles that are objective, better-crafted, and more detailed than is currently available in journals and handbooks Combines insights and scholarship across the breadth of health economics, where theory and empirical work increasingly come from non-economists Provides overviews of key policies, theories and programs in easy-to-understand language

The Regulation of Pharmaceuticals

Author : Henry G. Grabowski
Publisher : A E I Press
ISBN 13 :
Total Pages : 88 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis The Regulation of Pharmaceuticals by : Henry G. Grabowski

Download or read book The Regulation of Pharmaceuticals written by Henry G. Grabowski and published by A E I Press. This book was released on 1983 with total page 88 pages. Available in PDF, EPUB and Kindle. Book excerpt: The authors review the empirical evidence concerning the Food and Drug Administration's effect on the rate of innovation, the delays in introducing new drugs, and the profitability of pharmaceutical research.

Equitable Access to High-Cost Pharmaceuticals

Author : Zaheer-Ud-Din Babar
Publisher : Academic Press
ISBN 13 : 0128119624
Total Pages : 240 pages
Book Rating : 4.1/5 (281 download)

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Book Synopsis Equitable Access to High-Cost Pharmaceuticals by : Zaheer-Ud-Din Babar

Download or read book Equitable Access to High-Cost Pharmaceuticals written by Zaheer-Ud-Din Babar and published by Academic Press. This book was released on 2018-02-27 with total page 240 pages. Available in PDF, EPUB and Kindle. Book excerpt: Equitable Access to High-Cost Pharmaceuticals seeks to aid the development and implementation of equitable public health policies by pharmaco-economics professionals, health economists, and policymakers. With detailed country-by country analysis of policy and regulation, the Work compares and contrasts national healthcare systems to support researchers and practitioners identify optimal healthcare policy solutions. The Work incorporates chapters on global regulatory changes, health technology assessment guidelines, and competitive effectiveness research recommendations from international bodies such as the OECD or the EU. Novel policies such as horizon scanning, managed-entry agreement and post-launch monitoring are considered in detail. The Work also thoroughly reviews novel pharmaceuticals with particular research interest, including cancer drugs, orphan medicines, Hep C, and personalized medicines. - Evaluates impact and efficacy of current access policies and pricing regulation of high-cost drugs - Incorporates existing guidelines and recommendations by international organizations - Compares and contrasts how different countries fund and police high-cost drug access - Explores novel and emergent policies, including managed entry agreement, analysis of real world data and differential pricing - Reviews novel pharmaceuticals of current research interest

International Encyclopedia of Public Health

Author : William C Cockerham
Publisher : Academic Press
ISBN 13 : 0128037083
Total Pages : 4477 pages
Book Rating : 4.1/5 (28 download)

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Book Synopsis International Encyclopedia of Public Health by : William C Cockerham

Download or read book International Encyclopedia of Public Health written by William C Cockerham and published by Academic Press. This book was released on 2016-10-06 with total page 4477 pages. Available in PDF, EPUB and Kindle. Book excerpt: International Encyclopedia of Public Health, Second Edition, Seven Volume Set is an authoritative and comprehensive guide to the major issues, challenges, methods, and approaches of global public health. Taking a multidisciplinary approach, this new edition combines complementary scientific fields of inquiry, linking biomedical research with the social and life sciences to address the three major themes of public health research, disease, health processes, and disciplines. This book helps readers solve real-world problems in global and local health through a multidisciplinary and comprehensive approach. Covering all dimensions of the field, from the details of specific diseases, to the organization of social insurance agencies, the articles included cover the fundamental research areas of health promotion, economics, and epidemiology, as well as specific diseases, such as cancer, cardiovascular diseases, diabetes, and reproductive health. Additional articles on the history of public health, global issues, research priorities, and health and human rights make this work an indispensable resource for students, health researchers, and practitioners alike. Provides the most comprehensive, high-level, internationally focused reference work available on public health Presents an invaluable resource for both researchers familiar with the field and non-experts requiring easy-to-find, relevant, global information and a greater understanding of the wider issues Contains interdisciplinary coverage across all aspects of public health Incorporates biomedical and health social science issues and perspectives Includes an international focus with contributions from global domain experts, providing a complete picture of public health issues

Vaccines, Medicines and COVID-19

Author : Germán Velásquez
Publisher : Springer Nature
ISBN 13 : 3030891259
Total Pages : 129 pages
Book Rating : 4.0/5 (38 download)

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Book Synopsis Vaccines, Medicines and COVID-19 by : Germán Velásquez

Download or read book Vaccines, Medicines and COVID-19 written by Germán Velásquez and published by Springer Nature. This book was released on 2022-01-01 with total page 129 pages. Available in PDF, EPUB and Kindle. Book excerpt: This open access book is a collection of research papers on COVID-19 by Germán Velásquez from 2020 and early 2021 that help to answer the question: How can an agency like the World Health Organization (WHO) be given a stronger voice to exercise authority and leadership? The considerable health, economic and social challenges that the world faced at the beginning of 2020 with COVID-19 continued and worsened in many parts of the world in the second-half of 2020 and into 2021. Many of these countries and nations wanted to explore COVID-19 on their own, sometimes without listening to the main international health bodies such as WHO, an agency of the United Nations system with long-standing experience and vast knowledge at the global level and of which all countries in the world are members. In this single volume, the chapters present the progress of thinking and debate — particularly in relation to drugs and vaccines — that would enable a response to the COVID-19 pandemic or to subsequent crises that may arise. Among the topics covered: COVID-19 Vaccines: Between Ethics, Health and Economics Medicines and Intellectual Property: 10 Years of the WHO Global Strategy Re-thinking Global and Local Manufacturing of Medical Products After COVID-19 Rethinking R&D for Pharmaceutical Products After the Novel Coronavirus COVID-19 Shock Intellectual Property and Access to Medicines and Vaccines The World Health Organization Reforms in the Time of COVID-19 Vaccines, Medicines and COVID-19: How Can WHO Be Given a Stronger Voice? is essential reading for negotiators from the 194 member countries of the World Health Organization (WHO); World Trade Organization (WTO) and World Intellectual Property Organization (WIPO) staff participating in these negotiations; academics and students of public health, medicine, health sciences, law, sociology and political science; and intergovernmental organizations and non-governmental organizations that follow the issue of access to treatments and vaccines for COVID-19.