Chapter 1 United States Food and Drug Administration Regulation of Gene and Cell Therapies

Chapter 2 The National Institutes of Health Oversight of Human Gene Transfer Research: Enhancing Science and Safety

Chapter 3 Regulatory Oversight of Cell and Gene Therapy Products in Canada

Chapter 4 Overview of the Regulatory Oversight Implemented by the French Regulatory Authorities for the Clinical Investigation of Gene Therapy and Cell Therapy Products

Chapter 5 Regulation of Clinical Trials with Advanced Therapy Medicinal Products in Germany

Chapter 6 Marketing Regulatory Oversight of Advanced Therapy Medicinal Products (ATMPs) in Europe: The EMA/CAT Perspective.

Chapter 7 Requirements for Clinical Trials with Gene Therapy and Transplant Products in Switzerland

Chapter 8 Regulatory Frameworks for Gene and Cell Therapies in Japan

Chapter 9 Regulatory Oversight of Gene Therapy and Cell Therapy Products in Korea

Chapter 10 Regulation of Cell and Gene Therapy Medicinal Products in Taiwan

Chapter 11 Regulatory Oversight of Cell- and Tissue-Based Therapeutic Products and Gene Therapy Products in Singapore