Tsurumaki Yoshie, Kagawa Yusuke, Hayashi Shigeaki, Mizoguchi Hirokuni, Miyano Masaaki, Fujii Masaki, Shinozaki Ruriko, Kellathur Srinivasan N, Zhang Alex J, Suzuki Kunihiko, Nomura Masayuki
Novartis Pharma K.K., 23-1, Toranomon 1-chome, Minato-ku, Tokyo, 105-6333, Japan.
Japan Tissue Engineering Co., Ltd., 6-209-1 Miyakitadori, Gamagori, Aichi, 443-0022, Japan.
Regen Ther. 2025 Apr 14;29:404-418. doi: 10.1016/j.reth.2025.02.007. eCollection 2025 Jun.
The 7th Asia Partnership Conference of Regenerative Medicine (APACRM) was held both in person and online on April 25, 2024, to promote the regulatory harmonization of regenerative medicine products across Asia. Recognizing domestic regulatory guidelines and their underlying rationales within each country and region is an important initial step toward achieving harmonious regulation. The 7th APACRM featured open dialogues on the non-clinical evaluations of adeno-associated virus gene therapy products, regulation of gene therapies, considerations for conducting clinical trials, and provision of cell and gene therapies as medical practices without market authorization. These discussions included presentations by industry experts and panel discussions with regulatory agencies. The latest updates on regenerative medicine from each country and region were also introduced. This paper summarizes the proceedings of the 7th APACRM to foster future discussions and disseminate information to the public.
第七届亚洲再生医学伙伴关系会议（APACRM）于2024年4月25日以线下和线上相结合的方式举行，旨在促进亚洲各地再生医学产品的监管协调。认识到每个国家和地区的国内监管指南及其基本原理是实现和谐监管的重要第一步。第七届APACRM开展了关于腺相关病毒基因治疗产品的非临床评估、基因治疗的监管、进行临床试验的注意事项以及在未经市场授权的情况下作为医疗行为提供细胞和基因治疗等方面的公开对话。这些讨论包括行业专家的演讲以及与监管机构的小组讨论。还介绍了每个国家和地区再生医学的最新进展。本文总结了第七届APACRM的会议议程，以促进未来的讨论并向公众传播信息。
