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 12 The Regulatory Pathway for Advanced Cell Therapy and Gene Therapy Products in Brazil: A Road to Be Built