The Regulatory Challenge of Biotechnology

The Regulatory Challenge of Biotechnology PDF

Author: Han Somsen

Publisher: Edward Elgar Publishing

Published: 2007-01-01

Total Pages: 291

ISBN-13: 1847204414

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. . . a compilation of 12 invaluable contributions on this issue by internationally known experts in their respective fields. . . a valuable resource for academic professionals, policy makers and legislators, advocacy groups and scholars in legal and development studies. It is a storehouse of learning and practical knowledge for anyone interested in environmental policy, biosafety issues, biotechnology processes and associated regulatory constraints. Marcelin Tonye Mahop, Review of European Community and International Environmental Law For bioethicists, legal scholars and regulators struggling with what controls to place on biotechnology, this is required reading. John Avellanet, Journal of Commercial Biotechnology Biotechnology has prompted a revolution in science and society in the truest sense of the word. For what superficially appears to be a revolution in biotechnology, in effect touches upon the fundamentals of life and the way in which humans relate to it. This book will make a significant contribution to the debate surrounding the effective regulation of biotechnology. The contributing authors assess how regulatory regimes can accommodate the many different and often conflicting issues to which biotechnology is giving rise to (including a very tainted public image). The book s ultimate aim is to explore ways of designing a regulatory regime that takes heed of these different demands whilst, at the same time, answering to the imperatives of effectiveness and efficiency. The book synthesizes three fields of legal analysis; the first focuses on the risk-dominated regulation of GM food and bio-agriculture; the second involves human genetics as a field dominated by considerations of ethics. Finally, patent law has been chosen as an area captured by notions of property. With its holistic approach, The Regulatory Challenge of Biotechnology will be of great interest to academics, policymakers and regulators as well as biotechnology and law students.

Preparing for Future Products of Biotechnology

Preparing for Future Products of Biotechnology PDF

Author: National Academies of Sciences, Engineering, and Medicine

Publisher: National Academies Press

Published: 2017-07-28

Total Pages: 231

ISBN-13: 0309452058

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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.

An Introduction to Legal, Regulatory and Intellectual Property Rights Issues in Biotechnology

An Introduction to Legal, Regulatory and Intellectual Property Rights Issues in Biotechnology PDF

Author: Alessandro Stasi

Publisher: Bentham Science Publishers

Published: 2023-01-17

Total Pages: 165

ISBN-13: 9815080636

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Biotechnology, a branch of science and a fast-growing source of developing technologies, has shown immense potential for its utility across all the dimensions of our lives. Its applications range from drugs and therapeutics, industrial, household applications, biofuels, and information technology to almost all resource-based sectors, such as manufacturing, aquaculture, agriculture, and forestry. Biotechnology offers outstanding potential to meet the growing demand for food and energy production in a sustainable way. Recognizing its economic and strategic value, countries have implemented several measures to generate a homegrown biotechnology sector and help science-based companies develop. This book covers some of the most important legal issues arising in relation to biotechnology. Topics covered in chapters include 1) the historical development of a legal framework sufficient to protect public safety, 2) the current biotechnology regulatory system and the rules directing the primary agencies that regulate the products of biotechnology (namely the FDA, USDA and EPA), 3) the regulation of human genome editing and its impact on health research, 4) law and emerging genome editing technologies from recombinant DNA technology to CRISPR/Cas9 editing, 5) the development of legal principles to protect property rights in the human body and allow the efficient use of human tissue, organs, DNA, and cell-lines in medical research, and 6) legal issues arising from the use of genetic engineered plants and animals. The authors have ensured that the contents are easy to understand, making this an accessible reference for a broad range of readers. This book, therefore, serves as a quick summary of the prominent legal and regulatory issues in the biotech industry for professionals, as well as scholars in legal study programs.

Biotechnology

Biotechnology PDF

Author: Michael J. Malinowski

Publisher: Aspen Publishers

Published: 1999

Total Pages: 994

ISBN-13: 9780735503090

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Biotechnology: Law, Business, and Regulation offers comprehensive analysis on the advancement of a biotech discovery into a commercial product, making it easy for you to identify legal issues as they arise in the R & D and commercialization process; anticipate forthcoming legal and regulatory challenges; and develop an effective strategy for efficient commercialization. Real product and industry examples are used throughout the handbook and pending legislation is discussed and analyzed. This is the first book to pull together all the legal issues associated with the burgeoning biotechnology industry. The author explains and analyzes the current dimensions of biotechnology law, with in-depth attention to: the markets for biotech products -- patent protection -- confidentiality and other intellectual property issues -- government-supported cooperative R & D agreements -- corporate securities issues -- clinical trial agreements, including informed consent, liability, and insurance issues -- FDA regulation and tracks to speed product approval and commercialization -- legal implications of foreign R & D -- public health and policy considerations -- legislation prohibiting discrimination on the basis of genetic information -- and ethical norms of the scientific and medical communities.

Biotechnology Regulation and Trade

Biotechnology Regulation and Trade PDF

Author: Stuart J. Smyth

Publisher: Springer

Published: 2017-03-02

Total Pages: 286

ISBN-13: 3319532952

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This book discusses the regulatory and trade challenges facing the global adoption of biotechnological products and offers strategies for overcoming these obstacles and moving towards greater global food security. The first section of the book establishes the context of the conflict, discussing the challenges of global governance, international trade, and the history of regulation of genetically modified (GM) crops. In this section, the authors emphasize the shift from exclusively science-based regulation to the more socio-economically focused framework established by the Cartagena Protocol on Biosafety, which was adopted in 2000. The second section of the book provides a snapshot of the current state of international GM crop adoption and regulation, highlighting the US, Canada, and the EU. The final section of the book identifies options for breaking the gridlock of regulation and trade that presently exist. This book adds to the current literature by providing new information about innovative agricultural technologies and encouraging debate by providing an alternative to the narratives espoused by environmental non-governmental organizations. This book will appeal to students of economics, political science, and policy analysis, as well as members of regulatory agencies and agricultural industry firms.

Biotechnology And The Legal Landscape

Biotechnology And The Legal Landscape PDF

Author: Pooja Agarwal

Publisher:

Published: 2023-08-18

Total Pages: 0

ISBN-13: 9789358261400

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Biotechnology, a rapidly evolving field at the intersection of biology, technology, and innovation, has the potential to revolutionize various sectors, including healthcare, agriculture, and environmental sustainability. As biotechnology continues to advance, it is crucial to understand the legal framework surrounding its research, development, and commercialization. These chapters serves as an introduction to biotechnology and provides an overview of the legal aspects that govern its activities.

Fundamentals of Biologicals Regulation

Fundamentals of Biologicals Regulation PDF

Author: Rebecca Sheets

Publisher: Academic Press

Published: 2017-12-13

Total Pages: 450

ISBN-13: 0128094435

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Fundamentals of Biologicals Regulation: Vaccines and Biotechnology Medicines serves as an introduction to the international regulatory arena in which biologicals are developed and offers an overview of the processes and insight into the scientific concepts underpinning global regulations. This book will provide multiple levels of readership with guidance on basic concepts, a detailed look at regulatory challenges, and practical insight into how regulators consider regulatory science and regulatory process issues across various regions. With numerous case studies, learning activities, and real-world examples across several classes of biotechnological products, this book is a valuable and comprehensive resource for graduate students, professors, regulatory officials, and industry scientists working with biologicals. Provides a broad overview and introduction to the regulatory processes, from product development pathways, through clinical trials and product development stages and beyond Includes FDA, EMA, ICH, and WHO recommendations and guidelines so readers can compare and contrast the different regulatory regions with their expectations and understand why they are different Contains chapters on some of the exceptions to the process including how biosimilars and in vitro diagnostics are regulated Includes numerous case studies, learning activities, and real-world examples across several classes of biotechnological products

The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

The Challenge of CMC Regulatory Compliance for Biopharmaceuticals PDF

Author: John Geigert

Publisher: Springer Nature

Published: 2023-06-15

Total Pages: 597

ISBN-13: 3031319095

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Each year for the past three years, there have been about 50 new molecular medicines approved by the United States Food & Drug Administration (FDA), of which approximately 25% were new biopharmaceuticals. Over 200 recombinant proteins, monoclonal antibodies, antibody drug conjugates, fusion proteins, and Fab fragments are now in the marketplace in both the United States of America (USA) and European Union (EU). There are also now over 60 biosimilars available for all major classes of recombinant proteins and monoclonal antibodies. In addition, gene therapies using genetically engineered viruses and genetically engineered cells are now in the marketplace, and continually growing. This degree of change is reflected in the over 400 CMC regulatory compliance references listed in this book that were either issued or updated since the release of the third edition. Deficiencies in biopharmaceutical CMC regulatory compliance rarely result in termination of a product, but in can readily cause months if not years of delay in initiating clinical trials, or advancing clinical development stages, or even market approval. In summary, this book: Updates real-world CMC deficiency examples with current examples; Addresses current FDA and EMA requirements and expectations for CMC regulatory compliance; Now includes CMC regulatory compliance for the new gene-based biopharmaceuticals.

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