Work

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

Year: 2024

Type: article

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 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.

Source: Journal of Korean Society of Health-System Pharmacists

DOI: 10.32429/jkshp.2024.41.4.005

Authors: Jongyoon Kim, Kyung-Seon Oh, Hyang-Mi Lee

Institution: Dongduk Women's University

Language: English

Topic: Biomedical Ethics and Regulation

Subfield: Physiology

Field: Medicine

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: diamond

Funders: Korea Health Industry Development Institute, U.S. Food and Drug Administration