Abstract：
Chimeric Antigen Receptor-T cell (CAR-T) therapy has evolved as a revolutionary cancer treatment modality, offering remarkable clinical responses by harnessing the power of a patient\'s immune system to target and eliminate cancer cells. However, the development and commercialization of CAR-T cell therapies are accompanied by complex regulatory requirements and challenges. This therapy falls under the regulatory category of advanced therapy medicinal products. The regulatory framework and approval tools of regenerative medicine, especially CAR-T cell therapies, vary globally. The present work comprehensively analyses the regulatory landscape and challenges in CAR-T cell therapy development in four key regions: the United States, the European Union, Japan, and India. This work explores the unique requirements and considerations for preclinical studies, clinical trial design, manufacturing standards, safety evaluation, and post-marketing surveillance in each jurisdiction. Due to their complex nature, developers and manufacturers face several challenges. In India, despite advancements in treatment protocols and government-sponsorships, there are still several difficulties regarding access to treatment for the increasing number of cancer patients. However, India\'s first indigenously developed CAR-T cell therapy, NexCAR19, for B-cell lymphoma or leukemia, approved and available at a low cost compared to other available CAR-T therapies, raises great hope in the battle against cancer. Several strategies are proposed to address the identified hurdles from global and Indian perspectives. It discusses the benefits of aligning regulatory requirements across regions, eventually facilitating international development and enabling access to this transformative therapy.
摘要：
嵌合抗原受体-T细胞（CAR-T）疗法已经发展成为一种革命性的癌症治疗方式，通过利用患者免疫系统的力量来靶向和消除癌细胞，从而提供显著的临床反应。然而,CAR-T细胞疗法的开发和商业化伴随着复杂的监管要求和挑战。这种疗法属于高级治疗药物的监管类别。再生医学的监管框架和批准工具，尤其是CAR-T细胞疗法，全球不同。本工作全面分析了四个关键地区CAR-T细胞疗法发展的监管格局和挑战：美国，欧洲联盟,Japan,和印度。这项工作探讨了临床前研究的独特要求和注意事项，临床试验设计，制造标准，安全评价,以及每个司法管辖区的上市后监督。由于其复杂的性质，开发商和制造商面临着几个挑战。在印度,尽管治疗方案和政府赞助取得了进展，对于越来越多的癌症患者，在获得治疗方面仍然存在一些困难。然而,印度首个自主研发的CAR-T细胞疗法，NexCAR19，用于B细胞淋巴瘤或白血病，与其他可用的CAR-T疗法相比，以低成本获得批准，在与癌症的斗争中带来了巨大的希望。从全球和印度的角度提出了一些战略来解决已确定的障碍。它讨论了跨区域调整监管要求的好处，最终促进国际发展，并使人们能够获得这种变革性疗法。
