Abstract
The development of regenerative medicine focuses on cell therapy. The application of cell therapy in clinical treatment, which provides a possibility to cure some diseases that used to be incurable, has come of age in recent years, and so it makes the issue of cell therapy become important and forward-looking. Although emerging technologies bring a breakthrough and progress, they are also accompanied with unknown risks and security concerns at the same time. In order to impose regulations on such products, European countries and the United States all engaged in establishing regulations for cell therapy products. Cell therapy products have not appeared in Taiwan yet, but there are 26 clinical trials of cell therapy product application in progress. It is of the utmost importance that authority establishes proper regulatory system for such products. After analyzing current Taiwan medical regulations, the legislation has not been comprehensive even if relevant criteria of human cell therapy products are set. In addition to the vague position of human cell therapy products in current medical legislation, the regulation for clinical trials and registration of cell therapy products remains incomplete. Moreover, existing regulation of human cell therapy product consists of administrative rules. To reposition the human cell therapy products and enhance regulation become the main subjects in the future. That integrating the medical product regulations and examining the position of human cell therapy products in pharmaceutical products management should be firstly implemented is recommended in this thesis. Secondly, the management of human cell therapy products should base on the unique nature of those products to adjust existing drugs accelerate review process. In other words, conditional adjust current drugs accelerate review process for human cell therapy products. In the same time, to ensure the effectiveness and safety of the products, security tracking mechanism should be established, and inform concern should be properly fulfilled. Finally, the density of human cell therapy products regulation should base on the purpose of usage. In particular circumstances that products are designed for certain patients in hospital or clinical research and not for sale in market, the regulation density should be loosened. However, in order to ensure the safety of patients while promoting the development of researches, using unapproved human cells products in treatment should be limited in cases of serious illness or illness posing threat to life. . In other words, the disease will become increasingly serious and significantly affect the patient's activities in daily lives without treatment. On the other hand, if using unapproved human cells products in basic researches, those products should be managed in terms of the risk, namely adjusting the regulation density to the risk of the products.