Regulation of Regenerative Medicines: A Global Perspective
Table of Contents
Chapter 1: Introduction
Chapter 2: History of Regenerative Medicine
Chapter 3: Unique Properties of Regenerative Medicines: Key Differences From Small Molecules and Non-Regenerative Biologics
Chapter 4: Combination Products and Regenerative Medicine
Chapter 5: Special Considerations for Gene Therapy
Chapter 6: Gene Therapy and Viral Vectors: An Overview on Current Trends
Chapter 7: Special Considerations for Cell-Based Advanced Therapies
Chapter 8: Establishing Manufacturing Controls: A Hurdle for the Cell and Gene Therapy Industry
Chapter 9: Distribution of Regenerative Medicines
Chapter 10: Regulation of Regenerative Medicines in the US
Chapter 11: Understanding the Regulatory Framework for Regenerative Medicines in the European Union and the United Kingdom
Chapter 12: Regulation of Cell and Gene Therapies in Canada
Chapter 13: Regulation of Regenerative Medicines in Japan
Chapter 14: Cell and Gene Therapy Product Regulation in China
Chapter 15: Regulation of Regenerative Medicines in Australia and New Zealand
Chapter 16: Regulatory Environment of Cell, Tissue, and Gene Therapy Products in Singapore
Chapter 17: The Future of Regenerative Medicine
Jocelyn Jennings, MS, RAC (US, Drugs, Devices) and William Sietsema, PhD, editors
About the Book
Available formats: print and e-book
Regulation of Regenerative Medicines: A Global Perspective takes a comprehensive look inside the unique regulatory frameworks for cell therapy, gene therapy, and tissue engineering in the US and other key world markets, including Australia, Canada, China, Europe, Japan, and Singapore. This book is the first compendium of its kind to focus primarily on the rapidly evolving regenerative medicine landscape, encompassing human cells, tissues, and cellular and tissue-based products (HCT/Ps) and advanced therapy medicinal products (ATMPs). Written by dozens of global experts, this resource captures important elements of regenerative medicine regulations in all the regions where frameworks have been or are being established and addresses procedures used in each country, and, specifically, how to prepare for meetings with regulators and health authorities.
Regulation of Regenerative Medicines is divided into three distinct sections. Section I contains general information about regenerative medicines from definitions to the unique properties of regenerative medicines. Section II discusses special considerations for cell therapy, gene therapy, tissue engineering, manufacturing concepts, and distribution challenges. Section III covers the unique regulatory frameworks in multiple global regions, including Australia, Canada, China, Europe, Japan, Singapore, and the US, and looks forward to the future of regenerative medicine.
Regulation of Regenerative Medicines: A Global Perspective provides expert guidance to help navigate this rapidly evolving landscape, insight into the complex regulatory frameworks and procedures in specific countries, and impact of regenerative medicines as treatment options for rare diseases, liquid tumor cancers, and even more common disorders. The book also includes specialty areas, such as manufacturing, supply chain, distribution, expectations for pharmacology, pharmacokinetics, toxicology, and combination products as well as important elements to develop regulatory strategy and improve regulatory operations.
Who will benefit from this book?
Regulatory professionals at all levels of RAPS Regulatory Competency Framework will benefit from different aspects of this book. Regulatory professionals at Levels 1 and 2 of the framework will be able to easily access relevant regenerative medicine regulations and guidance in specific countries and how to apply them in one convenient place. For more senior professionals at Levels 3 and 4 responsible for global regulatory strategy, the book will serve as a comprehensive resource with valuable insight into critical issues facing the regulation of cell therapy, gene therapy, and tissue engineering as well as global aspects of relevant laws and guidance.
The publication of this first book addressing global regulation of regenerative medicines marks a seminal moment in the evolution of the regenerative medicine industry. By compiling all the relevant information in one place, this text becomes and timely and compulsory reference for all working in the field. I expect that it will contribute mightily to the further advancement and availability of this important class of therapies by facilitating thoughtful interaction between regulators and developers.
Purchasing Options
This book can be purchased in the following formats:
- Digital e-book. Single purchase; accessible online via RAPS Library online reader and downloadable.
- Printed book.
This book can also be purchased as part of the following bundles:
- All Access Library (12-month digital subscription)
Published by RAPS © 2022. Paperback. 238 pages. ISBN (print): 978-1-947493-77-3. ISBN (digital): 978-1-947493-78-0.
