International Medicines Regulations

Author : S.R. Walker,A.R. Griffin
Publisher : Springer Science & Business Media
Page : 318 pages
File Size : 44,6 Mb
Release : 2012-12-06
Category : Medical
ISBN : 9789400908574

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International Medicines Regulations by S.R. Walker,A.R. Griffin Pdf

As 1992 looms on the horizon and preparation is made for the completion of the internal market in Europe, the CMR realised the value of addressing some of the issues involved and defining the objectives and achievements of medicines regulations in a number of EEC countries in comparison with Japan and the USA. The overall aim was to use the lessons of past experience to determine the most appropriate way forward. The final debate focused on two possibilities for assessing and granting marketing authorisations for Europe, namely mutual recognition or a centrally organised European Med icines Office. These two views were discussed in detail at both the workshop at the Ciba Foundation and the international symposium at the Royal College of Physicians. It is hoped that this sharing of ideas and the publication of the proceedings of this fifth CMR Workshop will have encouraged all concerned to continue the debate so that the final outcome will be the establishment of an efficient system in the community for the benefit of patients, the practising physician and the pharmaceutical industry. We would like to take this opportunity of thanking Brenda Mullinger for the considerable amount of scientific and editorial work that she carried out on the manuscripts, Sheila Wright for providing the secretarial support which allowed the proceedings to be submitted to Kluwer Academic Publishers on disk and Sandra Cox who organised the administrative aspects so vital to the successful running of a Workshop and major international symposium. S. R.

Author : Centre for Medicines Research (Surrey, England). Workshop
Publisher : Unknown
Page : 312 pages
File Size : 43,8 Mb
Release : 1989
Category : Drugs
ISBN : 0852008228

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International Medicines Regulations by Centre for Medicines Research (Surrey, England). Workshop Pdf

Author : National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Global Health,Committee on Mutual Recognition Agreements and Reliance in the Regulation of Medicines
Publisher : National Academies Press
Page : 169 pages
File Size : 48,5 Mb
Release : 2020-04-25
Category : Medical
ISBN : 9780309498630

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Regulating Medicines in a Globalized World by National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Global Health,Committee on Mutual Recognition Agreements and Reliance in the Regulation of Medicines Pdf

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.

Author : Adrian Kilcoyne,Phil Ambery,Daniel O'Connor
Publisher : OUP Oxford
Page : 473 pages
File Size : 53,5 Mb
Release : 2013-05-23
Category : Medical
ISBN : 9780191510397

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Pharmaceutical Medicine by Adrian Kilcoyne,Phil Ambery,Daniel O'Connor Pdf

The breadth of the pharmaceutical medicine can be daunting, but this book is designed to navigate a path through the speciality. Providing a broad overview of all topics relevant to the discipline of pharmaceutical medicine, it gives you the facts fast, in a user-friendly format, without having to dive through page upon page of dense text. With 136 chapters spread across 8 sections, the text offers a thorough grounding in issues ranging from medicines regulation to clinical trial design and data management. This makes it a useful revision aid for exams as well as giving you a taster of areas of pharmaceutical medicine adjacent to your current role. For healthcare professionals already working in the field, this book offers a guiding hand in difficult situations as well as supplying rapid access to the latest recommendations and guidelines. Written by authors with experience in the industry and drug regulation, this comprehensive and authoritative guide provides a shoulder to lean on throughout your pharmaceutical career.

Author : Faraat Ali,Leo M.L. Nollet
Publisher : CRC Press
Page : 373 pages
File Size : 47,6 Mb
Release : 2024-07-05
Category : Medical
ISBN : 9781040044827

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Global Regulations of Medicinal, Pharmaceutical, and Food Products by Faraat Ali,Leo M.L. Nollet Pdf

Medicine regulation demands the application of sound medical, scientific, and technical knowledge and skills, and operates within a legal framework. Regulatory functions involve interactions with various stakeholders (e.g., manufacturers, traders, consumers, health professionals, researchers, and governments) whose economic, social, and political motives may differ, making implementation of regulation both politically and technically challenging. This book discusses regulatory landscape globally and the current global regulatory scenario of medicinal products and food products comprehensively. Features: Discusses how recent developments of medicinal and food products have opened up innovative solutions for many of the current challenges societies face presently. Explores the manifold variations between the regulatory bodies in different countries that have not previously been collected to this extent. Presents details on the substantial progress in analytical methodologies for labelling applications and the creation of appropriate test criteria for pharmaceuticals and their safety analysis. Reviews how more worldwide collaboration and cooperation in the regulatory area is still required.

Author : Institute of Medicine,Board on Health Sciences Policy,Board on Global Health,Committee on Strengthening Core Elements of Food and Drug Regulatory Systems in Developing Countries
Publisher : National Academies Press
Page : 366 pages
File Size : 47,7 Mb
Release : 2012-09-03
Category : Medical
ISBN : 9780309224086

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Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad by Institute of Medicine,Board on Health Sciences Policy,Board on Global Health,Committee on Strengthening Core Elements of Food and Drug Regulatory Systems in Developing Countries Pdf

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.

Author : Jack Wong,Raymond K. Y. Tong
Publisher : CRC Press
Page : 806 pages
File Size : 44,8 Mb
Release : 2022-01-27
Category : Medical
ISBN : 9781000440515

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Medical Regulatory Affairs by Jack Wong,Raymond K. Y. Tong Pdf

This handbook covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. It is the first to cover the medical device regulatory affairs in Asia. Experts from influential international regulatory bodies, including the US Food and Drug Administration (FDA), UK Medicines and Healthcare Products Regulatory Agency, Japan Pharmaceuticals and Medical Devices Agency, Saudi Food and Drug Authority, Korea Testing Laboratory, Taiwan FDA, World Health Organization, Asian Harmonization Working Party, Regulatory Affairs Professionals Society, and British Standards Institution, have contributed to the book. Government bodies, the medical device industry, academics, students, and general readers will find the book immensely useful for understanding the global regulatory environment and in their research and development projects.

Author : National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Global Health,Committee on Mutual Recognition Agreements and Reliance in the Regulation of Medicines
Publisher : National Academies Press
Page : 169 pages
File Size : 53,9 Mb
Release : 2020-03-25
Category : Medical
ISBN : 9780309498661

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Regulating Medicines in a Globalized World by National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Global Health,Committee on Mutual Recognition Agreements and Reliance in the Regulation of Medicines Pdf

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.

Author : Pierre-Louis Lezotre
Publisher : Academic Press
Page : 377 pages
File Size : 48,6 Mb
Release : 2013-12-05
Category : Medical
ISBN : 9780128005699

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International Cooperation, Convergence and Harmonization of Pharmaceutical Regulations by Pierre-Louis Lezotre Pdf

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

Author : Emily Jackson
Publisher : Bloomsbury Publishing
Page : 308 pages
File Size : 48,5 Mb
Release : 2012-03-01
Category : Law
ISBN : 9781847319098

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Law and the Regulation of Medicines by Emily Jackson Pdf

The principal purpose of this book is to tell the story of a medicine's journey through the regulatory system in the UK, from defining what counts as a medicine, through clinical trials, licensing, pharmacovigilance, marketing and funding. The question of global access to medicines is addressed because of its political importance, and because it offers a particularly stark illustration of the consequences of classifying medicines as a private rather than a public good. Two further specific challenges to the future of medicine's regulation are examined separately: first, pharmacogenetics, or the genetic targeting of medicines to subgroups of patients, and second, the possibility of using medicines to enhance well-being or performance, rather than treat disease. Throughout, the emphasis is on the role of regulation in shaping and influencing the operation of the medicines industry, an issue that is of central importance to the promotion of public health and the fair and equitable distribution of healthcare resources.

Author : Albert I Wertheimer
Publisher : CRC Press
Page : 390 pages
File Size : 49,8 Mb
Release : 2004-08-04
Category : Medical
ISBN : 0789025493

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International Drug Regulatory Mechanisms by Albert I Wertheimer Pdf

Learn how international governments have committed themselves to improving access to quality health care! International Drug Regulatory Mechanisms explores the environment, organization, structure, functioning, and finance of health systems and pharmaceutical markets in 19 countries. Local experts describe each country’s experiences with and lessons learned from the regulation of pharmaceutical products. This book will help government officials, pharmacy educators, and pharmaceutical industry leaders from around the globe identify and develop successful methods for controlling pharmaceutical drug prices and utilization. In International Drug Regulatory Mechanisms, you will learn about the health care system of each country and each government’s measures to control drug costs. This text shows you what government interventions are feasible as well as effective, and the impact of these measures on consumers, government agencies, and the pharmaceutical companies and distributors. Drug policies, reimbursement concepts, and health insurance companies are all examined to give you a better working knowledge of the methodology and guidelines involving drug control in nations such as: Iceland Canada Israel Malaysia Argentina Taiwan Mexico Italy International Drug Regulatory Mechanisms is an extensive text that shows how pharmaceuticals are regulated throughout the world. This book examines how—despite similar goals—price controls, utilization controls, record keeping, and quality requirements differ greatly between countries. Using numerous graphs, tables, and figures, this one-of-a-kind resouce provides you with new insight into which strategies are superior and how to implement these strategies in your own country.

Author : Sabrina Röttger-Wirtz
Publisher : Bloomsbury Publishing
Page : 417 pages
File Size : 53,5 Mb
Release : 2021-08-26
Category : Law
ISBN : 9781509943005

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The Interplay of Global Standards and EU Pharmaceutical Regulation by Sabrina Röttger-Wirtz Pdf

This book analyses the implementation of global pharmaceutical impact standards in the European risk regulation framework for pharmaceuticals and questions its legitimacy. Global standards increasingly shape the risk regulation law and policy in the European Union and the area of pharmaceuticals is no exception to this tendency. As this book shows, global pharmaceutical standards set by the International Council for Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH), after they are adopted through the European Medicines Agency (EMA), are an important feature of the regulatory framework for pharmaceuticals in the EU. In addition to analysing the influence of these global standards in the EU legal and policy framework, the book questions the legitimacy of the Union's reliance on global standards in terms of core administrative law principles of participation, transparency and independence of expertise. It also critically examines the accountability of the European Commission and the European Medicines Agency as participants in the global standard-setting and main implementation gateway of the global pharmaceutical standards into the European Union.

Author : Carine Baxerres,Maurice Cassier
Publisher : Routledge
Page : 285 pages
File Size : 47,6 Mb
Release : 2021-07-23
Category : Social Science
ISBN : 9781000413144

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Understanding Drugs Markets by Carine Baxerres,Maurice Cassier Pdf

Drawing on anthropology, historical sociology and social-epidemiology, this multidisciplinary book investigates how pharmaceuticals are produced, distributed, prescribed, (and) consumed, and regulated in order to construct a comprehensive understanding of the issues that drive (medicine) pharmaceutical markets in the Global South today. Based on primary research conducted in Benin and Ghana, and additional data collected in Cambodia and the Ivory Coast, this volume uses artemisinin-based combination therapies (ACTs) against malaria as a central case study. It highlights the influence of the countries colonial and post-colonial history on their models for state regulation, production, and distribution, explores the determining role transnational actors as well as industries from the North but also and increasingly from the South play in influencing local pharmaceutical markets and looks at the behaviour of health care professionals and individuals. Stepping back, the authors then unpick the pharmaceuticalization process and the multiple regulations at stake by looking at the workings of, and linkages between, (biomedical health) pharmaceutical systems, (representatives of companies) industries, actors in private distribution, and consumer practices. Providing a thorough comparative analysis of the advantages and disadvantages of different pharmaceutical systems, it is an important contribution to the literature on pharmaceutalization and the governance of medication. It is of interest to students, researchers and policy-makers interested in medical anthropology, the sociology of health and illness, global health, healthcare management and pharmacy.

Author : Albert I Wertheimer
Publisher : CRC Press
Page : 0 pages
File Size : 42,6 Mb
Release : 2004-08-16
Category : Medical
ISBN : 0789025485

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International Drug Regulatory Mechanisms by Albert I Wertheimer Pdf

Learn how international governments have committed themselves to improving access to quality health care! International Drug Regulatory Mechanisms explores the environment, organization, structure, functioning, and finance of health systems and pharmaceutical markets in 19 countries. Local experts describe each country’s experiences with and lessons learned from the regulation of pharmaceutical products. This book will help government officials, pharmacy educators, and pharmaceutical industry leaders from around the globe identify and develop successful methods for controlling pharmaceutical drug prices and utilization. In International Drug Regulatory Mechanisms, you will learn about the health care system of each country and each government’s measures to control drug costs. This text shows you what government interventions are feasible as well as effective, and the impact of these measures on consumers, government agencies, and the pharmaceutical companies and distributors. Drug policies, reimbursement concepts, and health insurance companies are all examined to give you a better working knowledge of the methodology and guidelines involving drug control in nations such as: Iceland Canada Israel Malaysia Argentina Taiwan Mexico Italy International Drug Regulatory Mechanisms is an extensive text that shows how pharmaceuticals are regulated throughout the world. This book examines how—despite similar goals—price controls, utilization controls, record keeping, and quality requirements differ greatly between countries. Using numerous graphs, tables, and figures, this one-of-a-kind resouce provides you with new insight into which strategies are superior and how to implement these strategies in your own country.

Author : Susan Walters (Dr),Organisation mondiale de la santé
Publisher : Unknown
Page : 142 pages
File Size : 49,6 Mb
Release : 2011
Category : Drugs
ISBN : 9241501456

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Marketing Authorization of Pharmaceutical Products with Special Reference to Multisource (generic) Products by Susan Walters (Dr),Organisation mondiale de la santé Pdf