Regulatory insights on gene therapies, adeno-associated virus-based gene therapies, cell/tissue-based products, and medical care/practice in cell and gene therapies: Report from the 7th Asia partnership conference - April 25, 2024

基因疗法、腺相关病毒基因疗法、细胞/组织产品以及细胞和基因疗法医疗保健/实践的监管见解:第七届亚洲合作会议报告 - 2024年4月25日

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Abstract

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.

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