A Comparative Study of International Regulatory Framework for Anti-Cancer Immune Cell Therapies

Background : Advanced therapy medicinal products (ATMPs) are innovative and complex biologics that play a leading role in modern medicine, especially in the field of cancer immunotherapy.This study examines chimeric antigen receptor T cell (CAR-T) and T cell receptor T cell (TCR-T) therapies, comparing the regulatory frameworks of the Republic of Korea, the United States (U.S.), and the European Union (EU).The goal is to identify similarities and differences among these frameworks and propose long-term improvements for the development and regulation of these therapies. Methods :This study is grounded in a thorough examination of official regulatory documents regarding immunotherapy, specifically cancer treatments, from the Ministry of Food and Drug Safety (MFDS), the European Medicines Agency (EMA), and the U.S. Food and Drug Administration (FDA) as of September 30, 2024.The search concentrated on terms associated with advanced therapy, cell therapy, gene therapy, and pertinent regulatory frameworks in the Republic of Korea, the U.S., and the EU.