Katherine Wang Analyzes Expanded Access to Investigational Drugs and Medical Devices in China
In a Thomson Reuters Practical Law UK and Practical Law China article, life sciences regulatory & compliance partner Katherine Wang (Shanghai) provides an overview of the Chinese legal regime regarding expanded access to investigational drugs and medical devices.
Katherine outlines requirements and responsibilities in relation to the expanded access program (EAP) under Chinese laws and regulations. She discusses the Food and Drug Administration's expanded access rules and compares the U.S. approach with the developing Chinese regime. She also examines how the Chinese expanded access regime may work in public health emergencies.