항암면역세포치료제의 국제 규제 체계 비교 연구

Abstract

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 improve ments for the development and regulation of these therapies. Methods : This study is grounded in a thorough examination of official regulatory docu ments 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. Results : The U.S. FDA’s Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) regulate advanced therapy medicinal prod ucts (ATMPs), including cellular and gene therapies such as CAR-T and TCR-T therapies. Similarly, the European Medicines Agency (EMA) and the Ministry of Food and Drug Safe ty (MFDS) oversee ATMPs through their respective frameworks, ensuring the safety and efficacy of these therapies while paying special attention to gene-modified cancer immu notherapies like CAR-T. Their regulatory guidelines are robust, providing a consistent approach across the U.S., EU, and Republic of Korea. Conclusion : This study shows that the Republic of Korea, the U.S., and Europe have com parable regulatory frameworks for advanced cell and gene therapies, even though there are differences in specific definitions and applications. Global pharmaceutical companies need to navigate these regional differences, and additional institutional support, including detailed guidelines for genome editing, is essential to foster international harmonization and future advancements in the field.