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

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.

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.

This addition to the 'Law and Global Governance Series' examines participation of stakeholders in treaty-based intergovernmental organizations. Readers are offered a comprehensive account of what has been done to facilitate the participation of previously neglected stakeholders.

With nanotechnology being a relatively new field, the questions regarding safety and ethics are steadily increasing with the development of the research. This book aims to give an overview on the ethics associated with employing nanoscience for products with everyday applications. The risks as well as the regulations are discussed, and an outlook for the future of nanoscience on a manufacturer’s scale and for the society is provided. Ethics in nanotechnology is a valuable resource for, philosophers, academicians and scientist, as well as all other industry professionals and researchers who interact with emerging social and philosophical ethical issues on routine bases. It is especially for deep learners who are enthusiastic to apprehend the challenges related to nanotechnology and ethics in philosophical and social education. This book presents an overview of new and emerging nanotechnologies and their societal and ethical implications. It is meant for students, academics, scientists, engineers, policy makers, ethicist, philosophers and all stakeholders involved in the development and use of nanotechnology.

Drugs Law and Legal Practice in Southeast Asia investigates criminal law and practice relevant to drugs regulation in three Southeast Asian jurisdictions: Indonesia, Singapore and Vietnam. These jurisdictions represent a spectrum of approaches to drug regulation in Southeast Asia, highlighting differences in practice between civil and common law countries, and between liberal and authoritarian states. This book offers the first major English language empirical investigation and comparative analysis of regulation, jurisprudence, court procedure, and practices relating to drugs law enforcement in these three states.

Dosage Form Design Parameters, Volume II, examines the history and current state of the field within the pharmaceutical sciences, presenting key developments. Content includes drug development issues, the scale up of formulations, regulatory issues, intellectual property, solid state properties and polymorphism. Written by experts in the field, this volume in the Advances in Pharmaceutical Product Development and Research series deepens our understanding of dosage form design parameters. Chapters delve into a particular aspect of this fundamental field, covering principles, methodologies and the technologies employed by pharmaceutical scientists. In addition, the book contains a comprehensive examination suitable for researchers and advanced students working in pharmaceuticals, cosmetics, biotechnology and related industries. Examines the history and recent developments in drug dosage forms for pharmaceutical sciences Focuses on physicochemical aspects, prefomulation solid state properties and polymorphism Contains extensive references for further discovery and learning that are appropriate for advanced undergraduates, graduate students and those interested in drug dosage design

The SAGE Encyclopedia of Pharmacology and Society explores the social and policy sides of the pharmaceutical industry and its pervasive influence in society. While many technical STM works explore the chemistry and biology of pharmacology and an equally large number of clinically oriented works focus on use of illegal drugs, substance abuse, and treatment, there is virtually nothing on the immensely huge business (“Big Pharma”) of creating, selling, consuming, and regulating legal drugs. With this new Encyclopedia, the topic of socioeconomic, business and consumer, and legal and ethical issues of the pharmaceutical industry in contemporary society around the world are addressed. Key Features: 800 signed articles, authored by prominent scholars, are arranged A-to-Z and published in a choice of electronic or print formats Although arranged A-to-Z, a Reader's Guide in the front matter groups articles by thematic areas Front matter also includes a Chronology highlighting significant developments in this field All articles conclude with Further Readings and Cross References to related articles Back matter includes an annotated Resource Guide to further research, a Glossary, Appendices (e.g., statistics on the amount and types of drugs prescribed, etc.), and a detailed Index The Index, Reader’s Guide, and Cross References combine for search-and-browse capabilities in the electronic edition The SAGE Encyclopedia of Pharmacology and Society is an authoritative and rigorous source addressing the pharmacology industry and how it influences society, making it a must-have reference for all academic libraries as a source for both students and researchers to utilize.

Drug Safety in Developing Countries: Achievements and Challenges provides comprehensive information on drug safety issues in developing countries. Drug safety practice in developing countries varies substantially from country to country. This can lead to a rise in adverse reactions and a lack of reporting can exasperate the situation and lead to negative medical outcomes. This book documents the history and development of drug safety systems, pharmacovigilance centers and activities in developing countries, describing their current situation and achievements of drug safety practice. Further, using extensive case studies, the book addresses the challenges of drug safety in developing countries. - Provides a single resource for educators, professionals, researchers, policymakers, organizations and other readers with comprehensive information and a guide on drug safety related issues - Describes current achievements of drug safety practice in developing countries - Addresses the challenges of drug safety in developing countries - Provides recommendations, including practical ways to implement strategies and overcome challenges surrounding drug safety

This book offers the first complete and up-to-date analysis of the European Union’s regulation of medicines. Through a reasoned description ranging from regulatory developments to the jurisprudence of the Court of Justice of the European Union, it delineates the current European pharmaceutical regulation system. Moreover, the economic and social implications caused by the market fragmentation linked to disparities in national pricing and reimbursement schemes of pharmaceuticals are also explored here. In what was theorized to be a patchwork of rules and roles, the potential growth of the pharmaceutical industry is hampered and important inequalities in patient access are growing. What will be the next moves of European Union legislation to address the aging of the population, the higher incidence of some diseases and the growing costs of innovative medicines? Answers to such questions are offered in this book.