With the maturation of the development of cell therapy technology, it has become an emerging medical method that is highly valued worldwide. Although several cell therapy products have been approved for marketing in the United States, Japan, and the European Union in recent years, extremely rare cases can be implemented in medical institutions in Taiwan. Recently, the Ministry of Health and Welfare has actively promoted the development of cell therapy according to the two directions: medical preparations (drugs) and medical technology. (1) Since 2017, TFDA has actively promoted the legislation of the draft regulations on the administration of regenerative medicinal products, which has now entered the review stage by legislature. The law formulates a strict management mechanism in order to prove the efficacy and safety of regenerative medicine preparations, perform clinical trials and require manufacturing in compliance with Good Manufacturing Practice (PIC/S GMP). On the other hand, a temporary license approval mechanism with incidental provisions with the valid period not more than five years has been established to provide multiple treatment options as soon as possible for patients with urgent medical needs. (2) The Department of Medical Affairs of the Ministry of Health and Welfare announced the revision of the Regulations Governing the Application or Use of Specific Medical Techniques or Examinations, or Medical Devices (abbreviated to Regulations of Special Medical Techniques) in September 2018, making Taiwan the second country after Japan to perform the cell therapy that has been implemented in the world, has low risk, or has reached a certain number of human trials in the form of medical technology management. This treatment options can apply cell therapy technology to patients with specific indications.
While major domestic medical centers and the biotechnology industry devote to the development of cell therapy, Chang Gung Hospital is developing forward-looking medical research. A new cell therapy center has been established in Taoyuan Chang Gung Hospital to establish a high-standard cell preparation site that exceeds the legal requirements, which assist the physicians in the hospital to perform cell therapy clinical trials, promote the research and development of emerging cell therapy products, cooperate with the aim of the development of cell therapy technology in the hospital, and assist the establishment of new cell therapy technology projects in our hospital.