Astellas Pharma Inc., Tokyo, Japan.
Daiichi Sankyo Co., Ltd., Tokyo, Japan.
Cytotherapy. 2023 Jul;25(7):683-698. doi: 10.1016/j.jcyt.2023.03.012. Epub 2023 Apr 24.
The 5th Asia Partnership Conference of Regenerative Medicine (APACRM) was held online on April 7, 2022 to promote regulatory harmonization of regenerative medicine products throughout Asia. The recognition of domestic regulatory guidelines within each country and region and the underpinning rationales are important initial steps toward the harmonization of regulations. The 5th APACRM featured open dialog regarding non-clinical, quality and environmental impact assessment settings for cell and gene therapy products through presentations from the industry and panel discussions with regulatory agencies. The latest updates on regenerative medicine fields in each country and region were also introduced. This paper summarizes the proceedings of the 5th APACRM for public dissemination to foster future discussion.
2022 年 4 月 7 日，第五届亚洲再生医学合作会议（APACRM）在线上举行，旨在促进亚洲范围内再生医学产品监管的协调统一。在每个国家和地区内对国内监管指南的认可及其基本原理是实现法规协调的重要初始步骤。第五届 APACRM 通过行业演讲和与监管机构的小组讨论，就细胞和基因治疗产品的非临床、质量和环境影响评估设置进行了公开对话。还介绍了每个国家和地区再生医学领域的最新进展。本文总结了第五届 APACRM 的会议记录，供公众传播，以促进未来的讨论。
