Adoption of Regulations for Cell Therapy Development: Linkage Between Taiwan and Japan

• Published in: Clinical and translational science Vol. 13; no. 6; pp. 1045 - 1047
• Main Authors: Tsai, Teng‐Huang, Ling, Thai‐Yen, Lee, Chung‐Hsi
• Format: Journal Article
• Language: English
• Published: United States John Wiley & Sons, Inc 01.11.2020; John Wiley and Sons Inc
• Subjects: Biomedical Technology - organization & administration; Biomedical Technology - standards; Biotechnology industry; Burns; Cancer therapies; Cell therapy; Cell- and Tissue-Based Therapy - standards; Clinical trials; Cooperation; FDA approval; Health Services Accessibility - organization & administration; Health Services Accessibility - standards; Health Services Needs and Demand - organization & administration; Health Services Needs and Demand - standards; Hospitals; Humans; International Cooperation; Japan; Marketing; Medical device industry; Medical equipment; Medical technology; Medical tourism; Medical Tourism - organization & administration; Medical Tourism - standards; Mini‐Review; Pharmaceuticals; Practice Guidelines as Topic; Regulation; Reviews; Taiwan; Japan; Taiwan; China
• ISSN: 1752-8054; 1752-8062
• DOI: 10.1111/cts.12813

Although cell‐based therapy has become a promising treatment, its practice and evaluation process remain unstandardized. Therefore, Japan initiated a dual‐track regulatory framework for cell‐based therapy aiming to promote and regulate the therapies to ensure that patients can access safe and effective treatments. Influenced by such pathway, Taiwan adopted the framework and initiated its own cell‐based therapy regulation in 2018. This paper discusses how Japan has influenced Taiwan in developing regulations for cell‐based therapy.