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Regulatory insights on adeno-associated virus-based gene therapies, cell- and tissue-based products, and CAR-T cell therapies: report from the 8th Asia Partnership Conference of Regenerative Medicine, April 24, 2025

Year: 2026

Type: article

Abstract: The 8th Asia Partnership Conference of Regenerative Medicine (APACRM) was held in a hybrid format—both in person and online—on April 24, 2025, to advance regulatory harmonization for regenerative medicine products across Asia. Understanding the domestic regulatory guidelines and their underlying rationales within each country and region represents a crucial first step toward achieving harmonized regulation. The 8th APACRM featured open discussions and case study presentations addressing the Quality by Design (QbD) approach in gene therapy manufacturing, non-clinical evaluation of adeno-associated virus (AAV)-based gene therapy products, the product lifecycle and regulatory landscape of AAV gene therapies, and post-launch regulatory requirements for regenerative medical products. The program included presentations by industry experts and panel discussions with representatives from regulatory agencies. The latest national and regional updates on regenerative medicine were also shared. This paper summarizes the proceedings of the 8th APACRM to facilitate future dialogue and promote the dissemination of regulatory information across the field. • Summarize key discussions and outcomes from the 8th APACRM meeting. • Illustrate Quality by Design strategies for consistent gene therapy manufacturing. • Compare non-clinical data requirements for adeno-associated virus gene therapies in Asia. • Identify challenges in regulatory frameworks, such as point-of-care manufacturing and real-world data use in Asia. • Survey post-marketing surveillance, re-examination, and re-evaluation systems in Asia.

Source: Regenerative Therapy

DOI: 10.1016/j.reth.2026.101074