{"id":7091,"date":"2025-02-25T07:40:49","date_gmt":"2025-02-24T23:40:49","guid":{"rendered":"https:\/\/be.tworg.app\/%e7%b4%b0%e8%83%9e%e6%b2%bb%e7%99%82iii%ef%bc%9a%e5%8f%b0%e7%81%a3%e6%94%bf%e7%ad%96%e8%88%87%e6%b3%95%e8%a6%8f%e8%a7%a3%e6%9e%90\/"},"modified":"2025-11-06T23:27:11","modified_gmt":"2025-11-06T15:27:11","slug":"%e7%b4%b0%e8%83%9e%e6%b2%bb%e7%99%82iii%ef%bc%9a%e5%8f%b0%e7%81%a3%e6%94%bf%e7%ad%96%e8%88%87%e6%b3%95%e8%a6%8f%e8%a7%a3%e6%9e%90","status":"publish","type":"post","link":"https:\/\/behealthventures.com\/ja\/%e7%b4%b0%e8%83%9e%e6%b2%bb%e7%99%82iii%ef%bc%9a%e5%8f%b0%e7%81%a3%e6%94%bf%e7%ad%96%e8%88%87%e6%b3%95%e8%a6%8f%e8%a7%a3%e6%9e%90\/","title":{"rendered":"\u7d30\u80de\u6cbb\u7642III\uff1a\u53f0\u7063\u653f\u7b56\u8207\u6cd5\u898f\u89e3\u6790"},"content":{"rendered":"\r\n
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Cell therapy is one of the categories of regenerative medicine. In Taiwan, thanks to the efforts of professionals, public and private groups, government agencies and administrative departments over the years, the Legislative Yuan passed the “Regenerative Medicine Act” and the “Regenerative Medicine Preparations Management Act” on June 4, 2024, hoping to benefit more patients while ensuring the safety, quality and efficacy of regenerative medicine.\u00a0<\/strong><\/span><\/p>\r\n<\/div>\r\n

Chen Changyi, Medical Affairs Manager, Biyi Biotech<\/div>\r\n
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The Development History of Cell Therapy in Taiwan<\/strong>\u00a0<\/div>\r\n
\u00a0In June 2015, the internationally shocking Formosa Fun Coast dust storm occurred. At the time, a large number of patients with extensive burns required emergency treatment and assistance. With the assistance of Japanese cell therapy technology, some patients benefited from the use of autologous artificial skin grafts, achieving good treatment results. This also made Taiwan aware of the development prospects and importance of cell therapy. In September 2018, the Ministry of Health and Welfare issued amended provisions of the “Regulations Governing the Implementation or Use of Specific Medical Technologies, Examinations, Tests, and Medical Instruments,” referred to as the “Special Regulations.” This law allows six cell therapy technologies to be clinically applied in approved medical institutions before clinical trials are fully completed, but must meet strict conditions, such as patient informed consent and monitoring of treatment effects. These technologies include autologous immune cells, autologous adipose stem cells, autologous bone marrow mesenchymal stem cells, autologous fibroblasts, and autologous chondrocytes. Meanwhile, the Ministry of Health and Welfare also began preparing the “Regenerative Medicine Act.” In 2023, it proposed two draft bills: the “Regenerative Medicine Act” and the “Regenerative Medicine Preparations Management Act.” These two draft bills adopt a dual-track system to regulate both medical technologies and products. They were passed by the Legislative Yuan on June 4, 2024, and implemented by presidential proclamation on June 19 of the same month. The implementation of these two laws reflects the Taiwanese government’s high regard for patient safety and technical standards, ensuring the safety and quality of regenerative medicine performed by medical institutions, and more importantly, protecting patients’ rights to receive related treatments.\u00a0<\/div>\r\n
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\u00a0<\/span>Current Status of Cell Therapy Development in Taiwan<\/strong>\u00a0<\/p>\r\n<\/div>\r\n

\u00a0With the rapid development of cell therapy technology and increasing medical needs, the number of related applications has been increasing year by year, including clinical trial applications and formal application licenses for treatment technologies. The application cases for the five major application technologies are summarized below (statistics as of June 30, 2024):\u00a0<\/div>\r\n
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